Clinical UM Guideline

This document addresses the use of radioactive seed localization (RSL). This is a technique used to provide localization of nonpalpable breast and lymphatic lesions before breast-conserving surgery. It can be used as an alternative to wire localization (WL) or radio-guided occult lesion localization (ROLL).

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Medically Necessary:

Radioactive seed localization of nonpalpable breast lesions is considered medically necessary as a method to localize a nonpalpable breast lesion in advance of surgical excision.

Radioactive seed localization is considered medically necessary to assist in targeted excision of positive axillary lymph nodes after neoadjuvant therapy.

Not Medically Necessary:

The use of radioactive seed localization is considered not medically necessary when the criteria above have not been met, including but not limited to use as a method to localize palpable breast lesions.

This document describes clinical studies and expert recommendations, and explains when radioactive seed localization (RSL) is clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

RSL is a way to help a surgeon find breast tissue or a lymph node that is hard to feel during an exam. A tiny radioactive seed is placed in the area before surgery using imaging such as a mammogram or ultrasound. During surgery, the surgeon uses a special probe to find the seed and remove the right tissue. RSL can be used instead of another method such as wire localization, which uses  a small piece of metal instead of a radioactive seed. RSL may make surgery planning easier because the seed can be placed before the day of surgery. Possible harms include seed movement, needing another method to find the area, or not being able to remove the seed.

What the Studies Show

Studies found that RSL and other methods (including wire localization, and radio-guided occult lesion localization) can work in similar ways when used before surgery to remove breast lesions that cannot be felt. Some studies found that RSL may lower the chance of needing a second surgery compared with wire localization. Some studies also found shorter surgery times with RSL.

Studies also looked at RSL for the treatment of underarm lymph nodes before chemotherapy that may be given before breast cancer surgery. The studies found that RSL helped surgeons find and remove lymph nodes that had tested positive for cancer before such treatment. This may help the care team check how well the cancer has responded to treatment.

When is Radioactive Seed Localization Clinically Appropriate?

RSL may be appropriate when the breast lesion cannot be felt during an exam and when RSL is being used before surgery to remove the lesion.

RSL may also be appropriate when:

• The person has positive axillary lymph nodes, which are underarm lymph nodes with cancer; and
• The person has had neoadjuvant therapy; and
• RSL is being used to help remove those lymph nodes.

When is this not Clinically Appropriate?

RSL is not clinically appropriate when the criteria above are not met. This includes use for breast lesions that can be felt during an exam.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

Associated Coding

When services may also be Medically Necessary for associated add-on codes when criteria are met for the related procedure codes listed above:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met; or when the code describes a procedure or situation designated in the Clinical Indications section as not medically necessary.

Summary

The location of nonpalpable breast and lymphatic lesions can be a challenge for treating providers, as by their nature they are difficult to locate without special equipment. The use of radioactive seed localization (RSL) and other methods allows the provider to place something in the breast or lymph node at the time of initial location to assist in identifying placement during follow-up evaluation and procedures. The available evidence indicates that RSL, wire localization (WL), and radio-guided occult lesion localization (ROLL) of nonpalpable breast lesions are at least as likely to produce equivalent therapeutic results when used to localize a nonpalpable breast lesion in advance of surgical excision. There is some good-quality evidence that indicates RSL has a decreased re-excision rate compared to WL and may have a shorter operative time. Use of RSL in the excision of positive axillary lymph nodes after neoadjuvant chemotherapy improves retrieval of previously biopsied lymph nodes.

Discussion

According to the American Cancer Society (ACS, 2026), there will be an estimated 321,910 new cases of invasive breast cancer diagnosed in 2026. Approximately 25% to 35% of identified breast cancers are nonpalpable at detection during mammography or by another method (Lovrics, 2011). Nonpalpable breast lesions may be difficult to locate during follow-up procedures such as surgery. To facilitate identification for later procedures, a variety of localization techniques have been developed, including WL, RSL, and ROLL. RSL placement is typically done in conjunction with mammography or ultrasonography for confirmation of the seed placement. RSL utilizes a low-dose, radio-opaque titanium seed containing iodine-125-labelled (I¹²⁵) which is placed into the center of the nonpalpable breast lesion with imaging guidance (for example, mammography or ultrasound). Locating the I¹²⁵ seed is done intraoperatively with a handheld gamma scan probe that can distinguish photons from the radioactive seed and the radiation from the radiotracer utilized for sentinel lymph node mapping. The computer-based control probe is able to provide approximate distance information for the surgeon to extract the I¹²⁵ seed along with the surrounding tissue (Barentsz, 2013; Dauer, 2013). Adverse events include migration of the seed, need for additional localization technique, and inability to retrieve the I¹²⁵ seed.

The current gold standard technique for localization is WL which involves the use of a thin, hooked wire that is inserted into the nonpalpable lesion, and the external portion of the wire is secured against the skin surface. Typically, later on the same day of wire placement, the surgeon then utilizes the wire to locate and resect the breast lesion. Challenges with the WL procedure include sequential scheduling of the procedures, dislocation of the wire before or during the surgical procedure, and the fact that the entry point of the wire is not always in the surgeon’s line of excision. Therefore, the surgeon still has to estimate the location of the tip of the wire and the breast lesion (Barentsz, 2013; Dauer, 2013; Lovrics, 2011).

Nonpalpable Breast Lesions

Donker (2013) reported the results of a study comparing ROLL with technetium-99 m colloid to RSL. This retrospective nonrandomized and nonblinded study involved 154 participants being treated with neoadjuvant systemic treatment who underwent breast-conserving surgery with the ROLL (n=83) or RSL (n=71). The authors reported no significant differences between groups with regard to median weight of the resected specimen (53 vs. 48 g), the median smallest margin (3.5 vs. 3.0 mm), and the risk for additional surgery for incomplete resections (7% vs. 8%). They concluded that ROLL and RSL demonstrated comparable results when used to perform breast-conserving surgery after neoadjuvant systemic treatment. Furthermore, they noted that because RSL does not require additional radiological localization shortly before surgery, it simplifies surgery scheduling.

In 2018, two retrospective non-randomized studies compared I¹²⁵ RSL to WL for non-palpable breast carcinoma in breast-conserving surgery (Da Silva, 2018; Milligan 2018). Milligan concluded that RSL was non-inferior to WL for non-palpable carcinoma in individuals undergoing breast-conserving surgery and Da Silva found that RSL serves as an alternative to WL. RSL was associated with a decreased re-excision rate and a lower rate of mastectomy when compared to WL.

A 2020 retrospective study by Jumaa also compared WL to RSL for nonpalpable breast lesions. There were 292 WL procedures and 194 RSL procedures completed. Data was collected regarding time from diagnosis to surgery, time from localization to surgery, resection margins, specimen size, seed loss, biopsy, and postoperative histology. For the WL surgeries, the mean time from diagnosis to surgery was 42.6 ± 18.8 days and WL were inserted on the day of surgery. Positive margins were present in 34 (17.2%) of 198 malignant lesions. Close margins (≤ 1 mm) were present in 31 (15.6%). Specimen size for malignant lesions was 6.8 ± 2.8 cm and 4.6 ± 1.7 cm for benign lesions. For the RSL surgeries, the mean time from diagnosis to surgery was 39.0 ± 15.0 days and a mean time from RSL insertion to surgery of 4.0 ± 2.8 days. Positive margins were present in 15 (10.3%) of 146 malignant lesions. Specimen size for malignant lesions was 6.9 ± 2.9 cm and 5.4 ± 2.7 cm for benign lesions. Close margins (≤ 1 mm) were present in 1 (0.6%). Seeds fell out of the specimen in six of the RSL cases with no seed loss recorded. More lumpectomies were performed with RSL as evidenced by a mean increment in the number of surgeries per month from 4.4 ± 2.6 for WL to 6.9 ± 3.5 for RSL.

There were two retrospective cohort studies which compared the rates of margin positivity and in-breast recurrence between RSL and WL in nonpalpable breast lesions for participants undergoing breast-conserving surgery. A 2018 study by Aljohani found no significant differences in margin positivity or local recurrence based on the type of localization method and a 2019 study by Angarita noted there were no differences in positive margin rates; RSL was noted to have smaller surgical specimens and shorter operation time when compared to WL.

A 2021 retrospective chart review by Law looked at 300 RSL cases and 300 WL cases and compared surgical margins, re-excision rate, re-operation, localization accuracy, major complications, and operative times between the two groups. Positive margin rates for invasive carcinoma were 7% for RSL and 6% for WL. Positive margin rates for in situ carcinoma were 6% for RSL and 8% for WL. Re-excision rate for RSL was 19% and 21% for WL. Reoperation rate was 11% for RSL and 17% for WL. There were no reported complications following RSL and 11 reported complications following WL. Operative times were not significantly different between the two groups.

In a 2025 retrospective review (Stephens, 2025), the authors compared surgical outcomes of three different techniques (radiofrequency identification [RFID], RSL, and WL) for resection of nonpalpable breast lesions during breast-conserving surgery. Primary outcomes included pathological margin status and rates of reoperation. Records were reviewed for 777 individuals (n=239 RFID, 347 RSL, 191 had WL). Between the three techniques, there were no statistically significant differences in positive margins (32 [13%] RFID vs. 55 [16%] RSL vs. 22 [11%] WL, p=0.387) nor in reoperation rates (59 [25%] RFID vs. 90 [26%] RSL vs. 34 [18%] WL, p=0.087).

Several randomized controlled trials have compared use of RSL to WL.

A randomized controlled trial by Lovrics in 2011 reported on 333 individuals who had planned for localization and breast-conserving surgery for confirmed invasive or ductal carcinoma in situ (DCIS). The WL group included 153 randomized participants and the RSL group had 152 participants, all who were treated between 2004 and 2010. There was no significant difference in the rates of positive margins between the groups (10.5% RSL vs. 11.8% WL; p=0.99). The mean excised tumor size was similar for both groups. The RSL group had a significantly shorter operative time of 19.4 minutes compared to the WL group’s 22.2 minutes (p<0.001). The satisfaction survey for radiologists and the participants did not show any significant differences. However, the surgeons had a satisfaction rating that favored RSL (p=0.008). Seed migration was reported in one RSL case and the wire migrated in two cases. In one case, the wire fell out during surgery. The surgeons were able to remove 100% of the index lesions successfully.

Another randomized controlled trial by Dauer (2013), involved the use of RSL in 1127 participants. They reported that the median length of time from RSL implant to surgical excision was 2 days. They also reported that the median I¹²⁵ activity at time of implant was 3.1 MBq (1.9 to 4.6). The median dose rate from individuals with a single seed was 9.5 µSv h-1 and 0.5 µSv h-1 at contact and 1 m, respectively. The maximum contact dose rate was 187 µSv h-1 from a superficially-placed seed. They concluded that RSL performed greater than 1 day before surgery is a viable alternative to WL, allowing flexibility in scheduling, minimizing day of surgery procedures, and improving workflow in breast imaging and surgery.

Bloomquist and colleagues (2016) reported the results of a randomized controlled trial involving 125 participants randomized to either RSL (n=75) or WL (n=55). The authors reported no significant differences between groups with regard to main specimen volume (p=0.67), volume of the first surgery (p=0.67), or rate of positive margins (p=0.53).

In 2017, Langhans reported the results of 378 participants with 390 breast lesions. Participants were assigned to undergo WL (n=192) or RSL (n=186). The authors reported that there were no significant differences between groups with regard to resection margins (p=0.65), margin status (p=0.62), duration of surgery (p=0.12), weight of the surgical specimen (p=0.54) or pain perception (p=0.28). They concluded that, “RSL offers a major logistic advantage, as localization can be done several days before surgery without any increase in positive resection margins compared with WGL.”

In a 2020 study, Agahozo and colleagues, the authors compared the efficacy of WL to RSL for participants treated with breast-conserving surgery for DCIS. There were 2187 participants treated with WL and 1851 participants treated with RSL. The authors report no significant differences in resection margin status (p=0.505) nor the number of re-excisions between both groups (p=0.429). However, when re-excision was done, the participants in the RSL group were more often treated with breast-conserving surgery than in the WL group (69.2% vs. 59.7%, respectively).

A 2021 randomized controlled trial by Taylor examined the re-excision and positive margin rates after localization with either RSL or WL in participants with non-palpable breast cancer. The authors also reported on resection volumes and weights. There were 327 participants in the RSL group and 332 participants in the WL group. The re-excision rate was 13.9% in the RSL group compared to 18.9% in the WL group. There were no significant differences in rates of positive margins between the two groups nor in volumes and weights of tissue specimens.

A 2025 randomized controlled trial by Hadzikadic-Gusic compared RSL to WL for those with non-palpable unifocal breast cancer. Primary outcome was comparison of negative margin rates. Secondary outcomes included time from consultation to surgery, time in radiology, surgery, and pathology, tissue weight, satisfaction, cost, adverse events, and complications. In this single-center study, 189 individuals who underwent RSL and 200 individuals who underwent WL were available for analysis of primary outcome. There were no significant differences in the negative margin rates (p=0.29) between the RSL 80% (95% CI, 75%-86%) and WL arms 85% (95% CI, 80%-89%). The median time from the initial consult to surgery was 26 days for RSL and 27 days for WL (p=0.62). The mean time in radiology was not significantly different between the two arms. Surveys completed by radiologists did not note detectable differences in ease or satisfaction between the two arms. The radiologists did rate RSL more favorably for convenience over WL (odds ratio [OR], 3.32; 95%CI: 1.65-6.69; p<0.01). Individuals in the RSL arm reported less pain, less anxiety, and greater overall satisfaction. The median time in surgery for all individuals was 89 minutes (interquartile range [IQR], 67-109 min). There were no significant differences in the median specimen surface area. There were 92 reported adverse events with the frequency being similar between the 2 arms; RSL 17.6% (33 of 188) compared to WL 15.9% (32 of 201) (p=0.69), most frequently being procedural related and infections. The rates of surgical complications were similar between the 2 arms, RSL 3.8% (7 of 184) compared to WL 3.6% (7 of 197) (p>0.99). The authors noted that RSL is an acceptable alternative to WL.

In a 2026 non-inferiority, randomized, open label, multicentered, cohort trial by Barranger, the authors reported RSL to WL for treatment of non-palpable breast lesions. There were 180 individuals in the WL arm and 173 individuals in the RSL arm included in the final analysis. Primary outcome included the quality of surgical excision (as defined by negative margins) with secondary outcomes including re-operation rate, localization time, duration of surgery, complications and satisfaction. The rate of incomplete resection was performed to 13.3 % in the RSL group and to 13.3 % in the WL group. Operative times were similar between the two groups as were levels of satisfaction. There were 18 individuals in the WL group and 17 individuals in the RSL group who required re-operation due to positive margins. Comparable outcomes are noted between the two comparison groups.

A population-based registry study by Schermers (2021) reported on 28,370 participants with non-palpable breast cancer who had a localization technique and were then assessed for the probability of reoperation. During the 5-year study period, the percentage of participants who had WL decreased from 75.4% to 31.6% while the percentage of those having radioactive seed localization increased from 15.7% to 61.1%. The authors noted that there were no statistically significant differences between the localization techniques (wire-guided versus radioactive seed) and rates of reoperation.

A 2024 systematic review with meta-analysis by Ferreira and colleagues compared RSL to ROLL and WL for individuals with nonpalpable breast cancer who were undergoing breast-conserving surgery. A total of 46 studies were included; 4 studies compared RSL and ROLL while 43 studies compared RSL and WL. In the studies which compared RSL to ROLL, three studies reported on positive surgical margin rates. The positive surgical margins risk in conservative surgery with RSL was lower than with ROLL, but it was not statistically relevant (relative risk [RR], 0.83, 95%, CI, 0.50-1.39). Four studies reported reoperation rates. The risk after conservative surgery with ROLL was lower than with RSL, but was not statistically relevant (RR, 1.14, 95% CI, 0.75-1.74. Three studies reported recurrence rates. Risk after conservative surgery with RSL was lower than with ROLL (RR, 0.50, 95% CI, 0.29-0.87). Of the 43 studies which compared RSL and WL, positive surgical margin rates were reported by 33 studies. The positive surgical margins risk in conservative surgery with RSL was lower than with WL (RR, 0.78, 95% CI, 0.70-0.87). There were 15 studies which reported intraoperative re-excision rates. The risk in conservative surgery with RSL was higher than with WL, but was not statistically relevant (RR, 1.02, 95% CI, 0.75-1.38). Reoperation rates were reported by 27 studies. The risk of reoperation after surgery with RSL was lower than with WL (RR, 0.71, 95% CI, 0.61-0.84). Recurrence rates were reported by 3 studies and showed risk after RSL was lower than with WL (RR, 0.41, 95% CI, 0.19-0.86). There were 6 studies which reported sentinel lymph node biopsy (SLNB) failure rates. The risk of SLNB failure associated with RSL and WL was equivalent (RR, 1.00, 95% CI, 0.35-2.87). Complication rates due to marker implantation were reported by 25 studies. The risk of complications with WL was lower than with RSL but was not statistically relevant (RR, 1.12, 95% CI, 0.66-1.78).

The National Comprehensive Cancer Network^® (NCCN) Clinical Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis (NCCN, 2026) notes use of radionucleotide seeds is being explored before an excisional biopsy of a nonpalpable lesion to direct surgical excision.

Targeted Excision of Positive Axillary Lymph Nodes

The use of RSL has been proposed for use in assisting the targeting of positive axillary lymph nodes after neoadjuvant therapy prior to excision. Diego and others (2016) published a retrospective review of 30 participants with biopsy-proven lymph nodes who had RSL placement prior to excision following neoadjuvant chemotherapy. The authors noted that all radioactive seeds were successfully retrieved and 29 of 30 nodes were successfully localized with RSL. There were 19 participants who had no residual axillary disease and 11 had persistent disease. All participants who remained node positive had disease in the biopsied nodes. The authors concluded that RSL combined with sentinel lymph node biopsy is a promising approach for axillary staging after neoadjuvant chemotherapy in individuals whose disease becomes cN0, and that the status of the lymph node after neoadjuvant chemotherapy predicted nodal status, suggesting that localization of the lymph node may be more accurate than SLNB alone for staging the axilla in the cN0 individual after neoadjuvant chemotherapy.

Another study by Caudle and others (2016) described the use of RSL in 208 participants with biopsy confirmed lymph node breast cancer metastases who were treated with neoadjuvant chemotherapy. All participants had I¹²⁵ seeds placed in the biopsied nodes under ultrasound guidance 1-5 days prior to surgery. This study evaluated the role of targeted axillary dissection in those with breast cancer after neoadjuvant chemotherapy compared to removal of all axillary lymph nodes. While no data is provided regarding the impact of RSL in this population, its use as a preferred method of localization over the use of wire localization should be noted.

In a 2023 retrospective review by Clark and colleagues, the authors evaluated the accuracy of RSL of axillary lymph node and compared the response to neoadjuvant chemotherapy in the breast and sampled axillary lymph nodes. There were 174 participants in total; 93 participants had biopsy-documented metastatic carcinoma in an axillary lymph node, 35 participants had a negative biopsy of axillary lymph node before neoadjuvant chemotherapy, and 46 participants did not have a pre-therapy axillary lymph node biopsy. For those with positive lymph nodes, therapy-related changes were more frequent in the breast (82/85, 96% of cases) than the sampled lymph nodes (67/85, 79%). Of the 93 participants with a biopsy-documented metastatic carcinoma, 38 showed no residual carcinoma in the lymph nodes. Of the 35 participants with a negative lymph node biopsy, retrieval of the biopsied lymph node was confirmed through presence of biopsy clip and/or biopsy site changes in 26/35 (74%) cases overall, and 7/7 cases (100%) in which RSL was used. The authors conclude use of RSL to assist in excision of positive axillary lymph nodes after neoadjuvant chemotherapy improves retrieval of previously biopsied lymph nodes.

A 2024 systematic review and pooled analysis (Alamoodi, 2024) assessed the performance of RSL in targeted axillary dissection among node-positive individuals undergoing neoadjuvant systemic therapy. There were six studies included encompassing 574 targeted axillary dissection procedures. The studies showed a 100% successful deployment rate, localization rate was 97.6%, and retrieval rate was 99.8%. There was a 60.0% concordance rate between SLNB and marked lymph node biopsy (MLNB). The false-negative rates of SLNB alone were higher than for MLNB (18.8% vs. 5.3%, respectively; p=0.001). There was a pathological complete response (pCR) observed in 44% of cases (248/564).

Neoadjuvant therapy: Treatment given as the first step to shrink a tumor before the main treatment.

Peer Reviewed Publications:

1. Agahozo MC, Berghuis SAM, van den Broek E, et al. Radioactive seed versus wire-guided localization for ductal carcinoma in situ of the breast: comparable resection margins. Ann Surg Oncol. 2020; 27(13):5296-5302.
2. Ahmed M, Douek M. Radioactive seed localisation (RSL) in the treatment of non-palpable breast cancers: systematic review and meta-analysis. Breast. 2013; 22(4):383-388.
3. Alamoodi M, Wazir U, Venkataraman J, et al. Assessing the efficacy of radioactive iodine seed localisation in targeted axillary dissection for node-positive early breast cancer patients undergoing neoadjuvant systemic therapy: a systematic review and pooled analysis. Diagnostics (Basel). 2024; 14(11):1175.
4. Al-Hilli Z, Glazebrook KN, McLaughlin SA, et al. Utilization of multiple I-125 radioactive seeds in the same breast is safe and feasible: a multi-institutional experience. Ann Surg Oncol. 2015; 22(10):3350-3355.
5. Aljohani B, Jumaa K, Kornecki A, Brackstone M. Clinical utility of radioactive seed localization in nonpalpable breast cancer: a retrospective single institutional cohort study. Int J Surg. 2018; 60:149-152.
6. Angarita FA, Acuna SA, Down N, et al. Comparison of radioactive seed localized excision and wire localized excision of breast lesions: a community hospital's experience. Clin Breast Cancer. 2019; 19(2):e364-e369.
7. Barentsz MW, van den Bosch MA, Veldhuis WB, et al. Radioactive seed localization for non-palpable breast cancer. Br J Surg. 2013; 100(5):582-588.
8. Barranger E, Najib B, Dejean C, et al. Iodine(125) grain isotope detection compared to standard metal guide detection for breast cancers: The IODINE BREAST, a randomised, non-inferiority trial. Eur J Surg Oncol. 2026; 52(2):111376.
9. Bloomquist EV, Ajkay N, Patil S, et al. A randomized prospective comparison of patient-assessed satisfaction and clinical outcomes with radioactive seed localization versus wire localization. Breast J. 2016; 22(2):151-157.
10. Caudle AS, Yang WT, Krishnamurthy S, et al. Improved axillary evaluation following neoadjuvant therapy for patients with node-positive breast cancer using selective evaluation of clipped nodes: implementation of targeted axillary dissection. J Clin Oncol. 2016; 34(10):1072-1078.
11. Clark BZ, Johnson RR, Berg WA, et al. Response in axillary lymph nodes to neoadjuvant chemotherapy for breast cancers: correlation with breast response, pathologic features, and accuracy of radioactive seed localization. Breast Cancer Res Treat. 2023; 200(3):363-373.
12. Da Silva M, Porembka J, Mokdad AA, et al. Bracketed radioactive seed localization vs bracketed wire-localization in breast surgery. Breast J. 2018; 24(2):161-166.
13. Dauer LT, Thornton C, Miodownik D, et al. Radioactive seed localization with 125I for nonpalpable lesions prior to breast lumpectomy and/or excisional biopsy: methodology, safety, and experience of initial year. Health Phys. 2013; 105(4):356-365.
14. Diego EJ, McAuliffe PF, Soran A, et al. Axillary staging after neoadjuvant chemotherapy for breast cancer: a pilot study combining sentinel lymph node biopsy with radioactive seed localization of pre-treatment positive axillary lymph nodes. Ann Surg Oncol. 2016; 23(5):1549-1553.
15. Diego EJ, Soran A, McGuire KP, et al. Localizing high-risk lesions for excisional breast biopsy: a comparison between radioactive seed localization and wire localization. Ann Surg Oncol. 2014; 21(10):3268-3272.
16. Donker M, Drukker CA, Valdés Olmos RA, et al. Guiding breast-conserving surgery in patients after neoadjuvant systemic therapy for breast cancer: a comparison of radioactive seed localization with the ROLL technique. Ann Surg Oncol. 2013; 20(8):2569-2575.
17. Ferreira HHJ, de Souza CD, Pozzo L, et al. Radioactive seed localization for nonpalpable breast lesions: systematic review and meta-analysis. Diagnostics (Basel). 2024; 14(4):441.
18. Gobardhan PD, de Wall LL, van der Laan L, et al. The role of radioactive iodine-125 seed localization in breast-conserving therapy following neoadjuvant chemotherapy. Ann Oncol. 2013; 24(3):668-673.
19. Gray RJ, Salud C, Nguyen K, et al. Randomized prospective evaluation of a novel technique for biopsy or lumpectomy of nonpalpable breast lesions: radioactive seed versus wire localization. Ann Surg Oncol. 2001; 8(9):711-715.
20. Hadzikadic-Gusic L, Bilz J, Boselli D, et al. A randomized, single-center, superiority trial of radioactive seed localization versus wire localization for malignant breast disease. Ann Surg. 2025; 282(6):998-1006.
21. Horwood CR, Grignol V, Lahey S, et al. Radioactive seed vs wire localization for nonpalpable breast lesions: a single institution review. Breast J. 2019; 25(2):282-285.
22. Hughes JH, Mason MC, Gray RJ, et al. A multi-site validation trial of radioactive seed localization as an alternative to wire localization. Breast J. 2008; 14(2):153-157.
23. Jumaa K, Johani BA, Brackstone M, Kornecki A. A single-institute experience with radioactive seed localization of breast lesions-a retrospective study. Can Assoc Radiol J. 2020; 71(1):58-62.
24. Langhans L, Tvedskov TF, Klausen TL, et al. Radioactive seed localization or wire-guided localization of nonpalpable invasive and in situ breast cancer: a randomized, multicenter, open-label trial. Ann Surg. 2017; 266(1):29-35.
25. Law W, Cao X, Wright FC, et al. Adequacy of invasive and in situ breast carcinoma margins in radioactive seed and wire-guided localization lumpectomies. Breast J. 2021; 27(2):134-140.
26. Lovrics PJ, Goldsmith CH, Hodgson N, et al. A multicentered, randomized, controlled trial comparing radioguided seed localization to standard wire localization for nonpalpable, invasive and in situ breast carcinomas. Ann Surg Oncol. 2011; 18(12):3407-3414.
27. McGhan LJ, McKeever SC, Pockaj BA, et al. Radioactive seed localization for nonpalpable breast lesions: review of 1,000 consecutive procedures at a single institution. Ann Surg Oncol. 2011; 18(11):3096-3101.
28. Milligan R, Pieri A, Critchley A, et al. Radioactive seed localization compared with wire-guided localization of non-palpable breast carcinoma in breast conservation surgery- the first experience in the United Kingdom. Br J Radiol. 2018; 91(1081):20170268.
29. Moreira IC, Ventura SR, Ramos I, et al. Preoperative localisation techniques in breast conservative surgery: a systematic review and meta-analysis. Surg Oncol. 2020; 35:351-373.
30. Murphy JO, Moo TA, King TA, et al. Radioactive seed localization compared to wire localization in breast-conserving surgery: initial 6-month experience. Ann Surg Oncol. 2013; 20(13):4121-4127.
31. Pouw B, de Wit-van der Veen LJ, Stokkel MP, et al. Heading toward radioactive seed localization in non-palpable breast cancer surgery? A meta-analysis. J Surg Oncol. 2015; 111(2):185-191.
32. Schermers B, van Riet YE, Schipper RJ, et al. Nationwide registry study on trends in localization techniques and reoperation rates in non-palpable ductal carcinoma in situ and invasive breast cancer. Br J Surg. 2021; 109(1):53-60.
33. Simons JM, van Nijnatten TJA, van der Pol CC, et al. Diagnostic accuracy of radioactive iodine seed placement in the axilla with sentinel lymph node biopsy after neoadjuvant chemotherapy in node-positive breast cancer. JAMA surgery. 2022: 157(11):991-999.
34. Stelle L, Schoenheit T, et al. Radioactive seed localization versus wire localization for nonpalpable breast lesions: a two-year initial experience at a large community hospital. Ann Surg Oncol. 2018; 25(1):131-136.
35. Stephens KR, Patel L, Malik DA, et al. Comparison of radiofrequency identification, radioactive seed, and wire localization techniques for non-palpable breast cancer. J Am Coll Surg. 2025; 241(3):339-346.
36. Sung JS, King V, Thornton CM, et al. Safety and efficacy of radioactive seed localization with I-125 prior to lumpectomy and/or excisional biopsy. Eur J Radiol. 2013; 82(9):1453-1457.
37. Taylor DB, Bourke AG, Westcott EJ, et al. Surgical outcomes after radioactive 125I seed versus hookwire localization of non-palpable breast cancer: a multicentre randomized clinical trial. Br J Surg. 2021; 108(1):40-48.
38. Theunissen CI, Rust EA, Edens MA, et al. Radioactive seed localization is the preferred technique in nonpalpable breast cancer compared with wire-guided localization and radioguided occult lesion localization. Nucl Med Commun. 2017; 38(5):396-401.
39. Tran VT, David J, Patocskai E, et al. Comparative evaluation of iodine-125 radioactive seed localization and wire localization for resection of breast lesions. Can Assoc Radiol J. 2017; 68(4):447-455.
40. van Riet YE, Jansen FH, van Beek M, et al. Localization of non-palpable breast cancer using a radiolabelled titanium seed. Br J Surg. 2010; 97(8):1240-1245.
41. Wang GL, Tsikouras P, Zuo HQ, et al. Radioactive seed localization and wire guided localization in breast cancer: a systematic review and meta-analysis. J BUON. 2019; 24(1):48-60.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Cancer Society. How common is breast cancer? June 24, 2026. Available at: https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html. Accessed on July 16, 2026.
2. NCCN Clinical Practice Guidelines in Oncology^®. 2026 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on June 15, 2026.
   • Breast Cancer Screening and Diagnosis (V1.2026). Revised March 5, 2026.
3. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. BrachySciences Radioactive Seed Localization Needle with AnchorSeed^® Summary of Safety and Effectiveness. K111979. Rockville, MD: FDA. October 18, 2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K111979.pdf. Accessed on July 16, 2026.
4. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Best^® Localization Needle with I-125 Seed Summary of Safety and Effectiveness. K122704. Rockville, MD: FDA. January 9, 2013. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf12/k122704.pdf. Accessed on July 16, 2026.

AnchorSeed^®
Best^® Localization Needle

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card.

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