Medical Policies - Radiology


Optical Coherence Tomography of the Breast

Number:RAD601.053

Effective Date:10-15-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Optical coherence tomography (OCT) of the breast is considered experimental, investigational and/or unproven as a pre-surgical, an intraoperative, or a post-surgical assessment of breast tissue cells from a lumpectomy, mastectomy, lymph-node dissection, and/or the surgical cavity or surrounding tissues (e.g., adipose tissue) examination.

Description:

Advances in optical imaging techniques enable observation of tissue microstructure at high resolution and in real time. Optical coherence tomography (OCT) is a rapidly emerging technology recently being researched to be used in clinical medicine and human biology to improve disease prevention, diagnoses, and treatment. This use of OCT may also be referred to as "computed optical margin assessment.”

Background

OCT is the optical analogue to ultrasound, in which reflected light is detected rather than sound. Light reflects off of the tissue and is captured by a detector. Image analysis software combines the signals from the reflected light to form an image, such as the breast. Optical imaging is often being considered a “biophotonic” imaging method, the science and technology of the interaction of photons within and on biological systems. (1-5)

OCT of the breast has the potential to reduce patient risk by the accurate and rapid assessment of tumor margins during breast cancer resection, such as during mastectomy, lumpectomy, and lymph node dissection. The National Institutes of Health (NIH) listed the advantages of OCT over existing radiological techniques (4):

Optical imaging uses non-ionizing radiation, significantly reducing patient radiation exposure and allows for repeated testing as needed.

OCT offers the potential to differentiate among soft tissues between native soft tissues and contrast media tagged tissues, a result of different photon absorption and scattering patterns/profiles at different wavelengths.

Optical imaging is complimentary to and easily combined with other imaging techniques (such as ultrasound, magnetic resonance imaging), amenable to multimodal imaging, for further diagnostics or screening in the future.

Utilizing intraoperative OCT improves the accuracy of surgical biopsies and assessing margin status. Tiny-fiber optic probes study cells of the surgical site without inflicting damage. Currently surgical samples are sent to the pathology laboratory during the breast surgery for inspection creating longer surgical times and/or post surgically for assessing cancer cell and healthy cell margins creating the need for repeat surgical procedures.

Regulatory Status

Only 2 OCT devices have been approved for marketing by the U.S. Food and Drug Administration (FDA). On May 13, 2016, the Perimeter Optical Tissue Imaging System (OTIS™) 1.0 Optical Coherence Tomography System (Perimeter Medical Imaging, Inc., Toronto, Canada) received FDA 510(k) premarket approval (K160240). Earlier in 2014, the Foresee (4C) Imaging System (Diagnostic Photonics, Inc., Chicago, Illinois) received FDA 510(k) premarket approval (K133209). Both of these devices are indicated for the use as an imaging tool in the evaluation of excised human tissue microstructure by providing 2-dimensional, cross-section, real-time depth visualization. FDA Product Code: NQQ.

Rationale:

This medical policy was created in 2014 and updated periodically with literature review of the MedLine database. The most recent update includes a literature search through July 2016. The following is a summary of the key literature.

Optical coherence tomography (OCT) of the breast is intended as an alternative to visual macroscopic and microscopic assessment to differentiate between normal and tumor tissue during a surgical procedure. Traditional resection procedures resulted in tissue samples sent to the laboratory for pathological assessment of suspicious areas, carefully slicing thin sections, staining and viewing under high-resolution microscopes to confirm the presence of tumor cells and determination if any are located along the surgical margin. These techniques are time-consuming and tend to significantly under-sample tissue, leaving many areas microscopically uninspected. (3) If done during the resection procedure, the surgery times are extended, an additional 20-30 minutes. If done post resection, the patient undergoes repeat surgical procedure(s). (6)

The most relevant type of studies evaluating the utility of OCT of the breast includes a head-to-head comparison between OCT and histologic assessment, currently considered the gold standard. (7) The peer-reviewed published literature reviewed via a MedLine search through April 2014, revealed data limited to case series and anecdotal use of OCT for breast procedures. The following is a summary of the key literature review.

Nguyen et al. studied 37 patients split between training and study groups. (8) OCT images were used and histologically correlated from 1 cm2 regions of lumpectomy surgical margin specimens. A 17-patient training set was used to establish standard imaging protocols and OCT evaluation criteria. The remaining 20 patients were enrolled in a feasibility study. Of the 20 patients, 11 were identified with a positive or close surgical margin and 9 were identified with a negative surgical margin using OCT. When based on histology examination, 9 true positives, 9 true negatives, 2 false positives, and 0 false negatives. This yielded a sensitivity of 100% and specificity of 82%. The researchers conclude OCT has the potential as a real-time method for assessment of surgical margins in breast surgeries.

A year later in 2010, Nguyen et al. reported the intraoperative examination of lymph nodes of the 17 patients (normal – 13, reactive – 1, and metastatic – 3) with breast cancer used as the training set from the 2009 study. (9) Scattering changes were identified in the specimens, which were used to differentiate normal from the reactive and metastatic nodes. These scattering changes correlate with the inflammatory and immunological changes observed in follicles and germinal centers of cells inspected. The authors concluded intraoperative OCT has the potential to assess in real-time node status without having to resect and histologically process tissue samples to visualize microscopic features. Thus, utilizing OCT reduced the number of samples taken from resecting the high number of lymph nodes when a small percentage of them were found to be metastatic, which is a fact to be weighed against potential complications, such as lymphedema.

A systematic review of the intraoperative methods for assessing margin status in breast conserving therapy was completed in 2014 by Butler-Henderson et al. (6) The criteria used to review the techniques included were the final pathology status, statistical measures including accuracy of tumor margin assessment, average time impact on the procedure and second operation rate. The researchers concluded that pathological methods (such as frozen section and imprint cytology) performed well, but added surgical time. The ultrasound probe allowed for timely accurate readings of the margins, but was limited in ductal carcinoma in situ (DCIS) samples due to the presence of calcification and in multifocal cancer. Additional research will be needed for intraoperative mammography, radiofrequency spectroscopy, and OCT.

In 2015, Erickson-Bhatt et al. published the results of a translational study evaluating the results derived from an OCT device to those from standard postoperative histopathological assessment in 35 subjects undergoing wide local excision surgery for breast cancer. (10) The authors reported that the ex vivo images from the OCT device yielded a sensitivity of 91.7% (95% confidence interval [CI], 62.5%-100%) and specificity of 92.1% (95% CI, 78.4%-98%). Study limitations include ex vivo OCT analysis and a small sample size.

In 2015, Zysk et al. published the results of a multicenter, prospective, blinded feasibility study assessing the final surgical margins during breast-conserving surgery and potential impact on patient outcomes. (12) Forty-six patients with a total of 2191 images from 229 shaved margins were collected and studied. Of the 8 patients (17%) with positive margins, the device identified positive margins in 5 (63%). Among patients with pathologically negative margins, an estimated mean additional tissue volume of 10.7 ml (»1% of overall breast volume) would have been unnecessarily removed due to false positives.

A search of the 2016 ECRI database did not reveal a technology report on OCT.

Ongoing and Unpublished Clinical Trials

An online search of site ClinicalTrials.gov through July 2016 identified no clinical trials that would likely influence this review.

Practice Guidelines and Position Statements

There are no professional guidelines and position statements that would likely influence this review.

Summary of Evidence

The use of optical coherence tomography (OCT) is promising, but the lack of large randomized clinical trials has not established consistent specificity in determining normal cells from tumor cells when utilized during or post breast surgical procedures. As a result, OCT is considered experimental, investigational and/or unproven as a pre-surgical, an intraoperative, or a post-surgical assessment of tissue cells from the breast from a lumpectomy, mastectomy, lymph-node dissection, and/or the surgical cavity or surrounding tissues (e.g., adipose tissue).

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0351T, 0352T, 0353T, 0354T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Kuo WC, Kim J, Shemonski ND, et al. Real-time three-dimensional optical coherence tomography image-guided core-needle biopsy system. Biomed Opt Express. Jun 1, 2012; 3(6):1149-61. PMID 22741064

2. Sullivan AC, Hunt JP, Oldenburg AL. Fractal analysis for classification of breast carcinoma in optical coherence tomography. J Biomed Opt. Jun 2, 2011; 16(6):066010-1. PMID 21721811

3. Boppart S. Point-of-care optical imaging and guidance for breast cancer surgery. SPIE Newsroom (2008 May 31):10.1117. Available at <http://www.spie.org > (accessed on May 27, 2014).

4. NIH – Optical Imaging, NIH Fact Sheets (2013 March 29). Prepared by the National Institutes of Health. Available at <http://www.report.nih.gov > (accessed on May 27, 2014).

5. NIH – Optical Coherence Tomography Poised to Improve Diagnostics, Science Highlight (2008 October 23). Prepared by the National Institutes of Health. Available at <http://www.nibib.nih.gov> (accessed on May 27, 2014).

6. Butler-Henderson K, Lee AH, Price RI, et al. Intraoperative assessment of margins in breast conserving therapy: a systematic review. Breast. Apr 2014; 23(2):112-9. PMID 24468464

7. McLaughlin RA, Scolaro L, Robbins P, et al. Imaging of human lymph nodes using optical coherence tomography: potential for staging cancer. Cancer Res. Apr 1, 2010; 70(7):2579-84. PMID 20233873

8. Nguyen FT, Zysk AM, Chaney EJ, et al. Intraoperative evaluation of breast tumor margins with optical coherence tomography. Cancer Res. Nov 15, 2009; 69(22):8790-6. PMID 19910294

9. Nguyen FT, Zysk AM, Chaney EJ, et al. Optical coherence tomography: the intraoperative assessment of lymph nodes in breast cancer. IEEE Eng Med Biol Mag. Mar-Apr 2010; 29(2):63-70. PMID 20659842

10. Erickson-Bhatt SJ, Nolan RM, Shemonski ND, et al. Real-time imaging of the resection bed using a handheld probe to reduce incidence of microscopic positive margins in cancer surgery. Cancer Res. 2015; 75(18):3706-12. PMID 26374464

11. Zysk AM, Chen K, Gabrielson E, et al. Intraoperative assessment of final margins with handheld optical imaging probe during breast-conserving surgery may reduce the reoperation rate: results of a multicenter study. Ann Surg Oncol. Oct 2015; 22(10):3356-62. PMID 26202553

Policy History:

DateReason
10/15/2017 Reviewed. No changes.
10/1/2016 Document updated with literature review. Coverage unchanged.
5/15/2015 Reviewed. No changes.
7/1/2014 New medical document. Optical coherence tomography of the breast is considered experimental, investigational and/or unproven as a presurgical, an intraoperative, or a post-surgical assessment of breast tissue cells from a lumpectomy, mastectomy, lymph-node dissection, and/or the surgical cavity or surrounding tissues (e.g., adipose tissue) examination.

Archived Document(s):

Back to Top