Single photon emission computed tomography (SPECT) provides three-dimensional images of the concentration of a radiopharmaceutical within various tissues and organs, and is an established imaging modality for a number of different indications. Radioimmunoscintigraphy of the breast, a specialized form of SPECT that is also called scintimammography, is also addressed in this document. Cardiovascular SPECT imaging is not addressed in this document, see CG-RAD-16 Myocardial Perfusion Imaging in the Outpatient Setting and CG-RAD-23 Cardiac Blood Pool and Infarct Imaging in the Outpatient Setting.

Note: Please see the following related documents for additional information:

• CG-RAD-08 CTA/MRA Head and Neck
• CG-RAD-16 Myocardial Perfusion Imaging in the Outpatient Setting
• CG-RAD-23 Cardiac Blood Pool and Infarct Imaging in the Outpatient Setting
• RAD.00002 Positron Emission Tomography (PET) and PET/CT Fusion

Medically Necessary:

SPECT scans are considered medically necessary for any of the following:

1. Bone and joint conditions—to differentiate between infectious, neoplastic, avascular or a traumatic process.
2. Brain tumors—to differentiate between lymphomas and infections such as toxoplasmosis particularly in the immunosuppressed, or recurrent tumor vs. radiation changes, when PET is not available.
3. Liver hemangioma—using labeled red blood cells to further define lesions identified by other imaging modalities.
4. Localization of abscess/infection/inflammation in soft tissues or cases of fever of unknown origin.
5. Neuroendocrine tumors (e.g., adenomas, carcinoid, pheochromocytomas, neuroblastoma, vasoactive intestinal peptide [VIP] secreting tumors, thyroid carcinoma, adrenal gland tumors)—using a monoclonal antibody (OctreoScan^™ [Covidien, Hazelwood, MO]) or I-131 meta-iodobenzyl-guanidine (MIBG).
6. Parathyroid imaging.

Not Medically Necessary:

SPECT scans are considered not medically necessary for the evaluation or management of cerebrovascular accident (CVA, stroke), subarachnoid hemorrhage, or transient ischemic attack. 

Investigational and Not Medically Necessary: 

For noncardiovascular indications, SPECT scans are considered investigational and not medically necessary, for all other purposes, including, but not limited to:

1. Attention Deficit and Hyperactivity Disorder.
2. Chronic fatigue syndrome.
3. Colorectal carcinoma (e.g., used with the monoclonal antibody or IMMU-4 and CEA-Scan^® [Immunomedics Inc., Morris Plains, New Jersey]).
4. Malignancies other than those listed as medically necessary.
5. Neuropsychiatric disorders without evidence of cerebrovascular disease.
6. Prostate carcinoma (e.g., used with the monoclonal antibody ProstaScint^® [EUSA Pharma, Langhorne, PA], with or without fusion imaging with computed tomography or magnetic resonance imaging).
7. Scintimammography for breast cancer.

Currently there is sufficient evidence in the peer-reviewed medical literature in the form of properly randomized controlled clinical trials to support the use of SPECT in a variety of disease processes. The literature supports the clinical effectiveness and safety of this imaging for the diagnosis and evaluation of selected oncologic diseases, the evaluation of some specific central nervous system (CNS) disorders (e.g., brain tumor, toxoplasmosis) and the investigation of bone, joint and soft tissue disorders for inflammation or infection. SPECT has been shown to be safe and effective for the monitoring of changes in these conditions over time, comparable to the gold standard of positron emission tomography (PET) scanning. In addition, non-randomized but controlled clinical trials have established the safety and efficacy of SPECT in identifying infections. Early identification of acute infection, such as in appendicitis, may be critical to early intervention and positive outcome.

However, the efficacy of SPECT for most other applications has not been firmly established due to the lack of comprehensive studies for each application.

Radioimmunoscintigraphy, a specialized form of SPECT, may also be called scintimammography when used in breast imaging. Scintimammography has not been shown to improve health outcomes in individuals with breast cancer, populations being screened for breast cancer or as an adjunct for diagnostic or surgical treatment planning. At this time, literature is limited to small, uncontrolled retrospective studies that do not document outcome improvement with this imaging method. An assessment on scintimammography reported the following conclusions:

• As a second-line diagnostic test after mammography, the sensitivity and corresponding negative predictive value of scintimammography are not high enough to influence treatment decisions. Specifically, even at the low end of the intermediate range of prevalence for malignancy, if a negative scintimammogram were to be used to recommend against doing biopsy, the risk of undetected malignancy would be 4.3%. This was considered too high given the relatively low morbidity of breast biopsy, the gold standard.
• There were inadequate data to permit conclusions regarding the use of scintimammography for staging of axillary lymph nodes.
• For other patient populations, including but not limited to, women with a breast lesion who have been referred for biopsy but who have a low probability of malignancy, women who have a probable benign finding on mammography and who are recommended for close follow-up, and women with dense breast tissue, the available evidence is insufficient to permit conclusion as to the effectiveness of scintimammography (Sampalis, 2003).

The use of SPECT for the evaluation and management of cerebrovascular disease, including cerebrovascular accident (CVA, stroke), subarachnoid hemorrhage, and transient ischemic attack has been superseded by newer more accurate imaging modalities. In recent years the use of magnetic resonance angiography (MRA) and computed tomography angiography (CTA) has become the standard of care for these conditions and the use of SPECT has become obsolete in the presence of superior technologies. Advances in other imaging modalities such as PET, has also led to SPECT no longer being used for conditions such as epilepsy and certain types of cancer including lymphoma.

A search of the peer-reviewed literature found that the use of SPECT for dementias such as Alzheimer's disease and motor system disorders such as Parkinson's disease is being investigated. However, at this time, the studies are limited to a small number of individuals.

ProstaScint, a monoclonal antibody (capromab pendetide) combined with radioactive indium-111, is used to detect prostate cancer. It is injected into the body and a gamma camera (designed to detect radioactivity) is then used to locate any prostate cancer cells. ProstaScint shows potential benefit, but in the current peer-reviewed literature there is a paucity of evidence demonstrating improved progression-free survival following ProstaScint scans (including fusion with computed tomography or magnetic resonance imaging). In a study by Koontz (2008), forty patients who had prostate specific antigen (PSA) recurrence after total prostatectomy were scanned prior to salvage prostate bed radiotherapy. Twenty patients had negative scans and twenty patients had locally positive scans. Two-year progression-free survival rates were 60% for those patients with a negative scan and 74% for those patients with a positive scan. The researchers concluded that individuals "with locally positive scans did not have statistically different progression-free survival than those with a negative scan result." Pucar and colleagues (2008) concluded that "ProstaScint has no added benefit over other imaging modalities in evaluating post-radical prostatectomy recurrence, due to its low sensitivity for detecting local recurrences and bone metastases." A recent prospective trial of 25 hormone-naive men with clinically localized prostate cancer who received ProstaScint scanning with blinded correlation by a radiologist and pathologist found that sensitivity ranged from only 37% to 87%, and specificity from 0% to 50%, and that the scan seemed to have comparable affinity for both benign and malignant prostate tissue (Mouraviev, 2009).

Single photon emission computed tomography (SPECT) is an imaging method designed to provide information about the functional level of a specific part of the body. SPECT involves the injection of a low-level radioactive chemical, called a radiotracer, into the bloodstream. The images obtained reflect the manner in which the tracer is processed by the body and thus this technology provides functional information in contrast to the structural information provided by computed tomography (CT), magnetic resonance imaging (MRI) and ultrasound. Using various imaging protocols, scans are made with a device that can detect radioactivity in the body. Detailed information is generated by a SPECT camera, gamma camera, or tomograph. Such imaging is called tomography. Each radiotracer used with SPECT is a radiation emitting substance that is used alone or attached to an element appropriate for obtaining specific information. For example, certain types of proteins called antibodies attach to specific types of tumors. The radiotracer can be attached to the antibodies so that they bind to the tumors, and thus can be identified and located.

SPECT can provide information about the level of chemical or cellular activity within an organ or system as well as provide structural information. This process may show areas of increased activity such as the inflammation in an abscess. Patterns of distribution of the radiotracer can be correlated with various diseases. SPECT has been of particular use in early detection in brain and bone disorders, as well as development of some types of malignancies. The radiotracer used and imaging protocol are specific to the disease process being investigated. SPECT scans may be repeated to follow the course of a disease.

SPECT is typically performed without the need of a hospital stay. The individual is given a dose of a radiotracer, which circulates in the bloodstream and binds to specific target cells. The emitted radiation from the radiotracer travels through body with little interference and is imaged. SPECT cameras can image large areas of the body, or the entire body.

Information acquired by SPECT frequently adds or confirms observations obtained by other testing. SPECT may also provide information not obtainable by means other than PET. PET is a newer technology and may provide additional information in some settings. The images obtained through PET tend to be of a higher quality than those provided by SPECT however, the availability, sensitivity and specificity and impact on clinical outcomes using PET varies by clinical condition. For many conditions, SPECT has been found to be as useful as PET and it is generally more available.

Both PET and SPECT may reveal the presence of disease prior to the appearance of any symptoms or structural expressions of disease, by providing information about the level of function within a body system. Computed tomography (CT), MRI, and planar scintigraphy are alternatives for providing structural information. However, these techniques provide no information about function and are often inadequate to diagnose or evaluate disease processes.

Abscess: collection of pus, often caused by the body's response to an infection

Adenoma: a benign tumor that arises in or resembles glandular tissue

Carcinoid syndrome: a syndrome due to carcinoid tumors that secrete large amounts of the hormone serotonin; carcinoid tumors usually arises in the gastrointestinal tract, anywhere between the stomach and the rectum and may metastasize (spread) to the liver

Colorectal carcinoma: cancer of the colon and rectum; a malignant tumor arising from the inner wall of the large intestine

Liver hemangioma: the most common benign tumor of the liver; it is made up of small blood vessels and is 4-6 times more common in women than men

Neuroendocrine tumors: a diverse group of tumors, such as carcinoid, islet cell tumors, neuroblastoma, and small cell carcinomas of the lung; all have dense granules and produce polypeptides that can be identified by immunochemical methods

Subarachnoid hemorrhage: bleeding in the space between the two membranes that surround the brain

Transient ischemic attack (TIA): a neurological event with the signs and symptoms of a stroke, but which go away within a short period of time; also called a mini-stroke, a TIA is due to a temporary lack of adequate blood and oxygen (ischemia) to the brain

The following codes for treatments and procedures applicable to this document 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.

Bone and joint; inflammatory processes
When services are Medically Necessary:

Brain
When Services  may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above, for the following diagnoses

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Liver, Tumors, other
When Services are Medically Necessary:

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary:
For the following procedure codes for all diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Brem RF, Fishman M, Rapeiyea JA. Detection of ductal carcinoma in situ with mammography, breast specific gamma imaging, and magnetic resonance imaging: a comparative study. Acad Radiol. 2007; 14(8):945-950.
2. Chiou JF, Lin MC, Chen DR, et al. Usefulness of thallium-201 SPECT Scintimammography to differentiate benign from malignant breast masses in mammographically dense breasts. Cancer Invest. 2003; 21(6):863-868.
3. Coover LR, Caravaglia G, Kuhn P. Scintimammography with dedicated breast camera detects and localizes occult carcinoma. J Nucl Med. 2004; 45(4):553-558.
4. Fondrinier E, Muratet JP, Anglade E, et al. Clinical experience with 99mTc-MIBI Scintimammography in patients with breast microcalcifications. Breast. 2004; 13(4):316-320.
5. Gadzicki M, Bikiewicz M, Modkowska E, et al. Cortical scintigraphy in the evaluation of renal defects in children with vesico-ureteral reflux--optimization of the procedure and study interpretation. Nucl Med Rev Cent East Eur. 2004; 7(2):157-164.
6. Haseman MK, Rosenthal SA, Kipper SL, et al. Central abdominal uptake of indium-111 capromab pendetide (ProstaScint) predicts for poor prognosis in patients with prostate cancer. Urology. 2007; 70(2):303-308.
7. Khalkhali I, Baum JK, Villanueva-Meyer J, et al. (99m)Tc sestamibi breast imaging for the examination of patients with dense and fatty breasts: multicenter study. Radiology. 2002; 222(1):149-155.
8. Koontz BF, Mouraviev V, Johnson JL, et al. Use of local (111)in-capromab pendetide scan results to predict outcome after salvage radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2008; 71(2):358-361.
9. Liu C, Chin T, Wei C. Contralateral reflux after unilateral ureteral reimplantation--preexistent rather than new-onset reflux. J Pediatr Surg. 1999; 34(11):1661-1664.
10. Mohammed AA, Shergill IS, Vandal MT, Gujral SS. ProstaScint and its role in the diagnosis of prostate cancer. Expert Rev Mol Diagn. 2007; 7(4):345-349.
11. Mouraviev V, Madden JF, Broadwater G, et al. Use of 111in-capromab pendetide immunoscintigraphy to image localized prostate cancer foci within the prostate gland. J Urol. 2009; 182(3):938-947.
12. Nagda SN, Mohideen N, Lo SS, et al. Long-term follow-up of 111In-capromab pendetide (ProstaScint) scan as pretreatment assessment in patients who undergo salvage radiotherapy for rising prostate-specific antigen after radical prostatectomy for prostate cancer. Int J Radiat Oncol Biol Phys. 2007; 67(3):834-840.
13. Noz ME, Chung G, Lee BY, et al. Enhancing the utility of prostascint SPECT scans for patient management. J Med Syst. 2006; 30(2):123-132.
14. Proao JM, Sodee DB, Resnick MI, Einstein DB. The impact of a negative (111)indium-capromab pendetide scan before salvage radiotherapy. J Urol. 2006; 175(5):1668-1672.
15. Pucar D, Sella T, Schöder H. The role of imaging in the detection of prostate cancer local recurrence after radiation therapy and surgery. Curr Opin Urol. 2008; 18(1):87-97.
16. Sampalis FS, Denis R, Picard D, et al. International prospective evaluation of Scintimammography with (99m)technetium sestamibi. Am J Surg. 2003; 185(6):544-549.
17. Schillaci O, Scopinaro F, Spanu A, et al. Detection of axillary lymph node metastases in breast cancer with Tc-99m tetrofosmin scintigraphy. Int J Oncol. 2002; 20(3):483-487.
18. Spanu A, Dettori G, Nuvoli S, et al. (99)mTc-tetrofosmin SPET in the detection of both primary breast cancer and axillary lymph node metastasis. Eur J Nucl Med. 2001; 28(12):1781-1794.
19. Uchida Y, Minoshima S, Okada S, et al. Diagnosis of dementia using perfusion SPECT imaging at the patient's initial visit to a cognitive disorder clinic. Clin Nucl Med. 2006; 31(12):764-773.
20. Zhou M, Johnson N, Gruner S, et al. Clinical utility of breast-specific gamma imaging for evaluating disease extent in the newly diagnosed breast cancer patient. Am J Surg. 2009; 197(2):159-163.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Centers for Medicare and Medicaid Services. National Coverage Determination: Single Photon Emission Computed Tomography (SPECT). NCD #220.12. Effective October 1, 2002. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on April 8, 2010.

1. Society of Nuclear Medicine. http://www.snm.org/. Accessed on April 8, 2010.

Scintimammography
SPECT Scans

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