Medical policy: Handheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins During Breast Conserving Surgery

Número de política: MP 5.055

Fecha de entrada en vigor: 6/1/2026

Política

Handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins during breast-conserving surgery is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Refer to FEP medical policy manual. The FEP medical policy manual can be found at: FEP Medical Policy Manual.

Descripción/antecedentes

As part of the treatment of localized breast cancer, breast-conserving surgery is optimally achieved by attaining tumor-free margins around the surgical resection site. Failure to achieve clear margins will often require additional surgery to re-excise breast tissue. Currently, histologic examination of excised tissues after completion of surgery is the only method to determine definitively whether clear margins were achieved. Intraoperative methods of assessing surgical margins, such as specimen imaging, frozen section pathology, and touch print cytology, are either inaccurate, not commonly available, or require considerable time and resources.

A device to detect positive margins should have a high sensitivity, indicating the ability to accurately detect any tumor found in the margins, ideally above 95%. While specificity is less important, excess false-positive margin detection would lead to additional unnecessary tissue removal. A new device should have a specificity at least matching current standard best practices, estimated at 85%.

The MarginProbe is an intraoperative device which uses radiofrequency spectroscopy to measure the dielectric properties of tissue into which it comes in contact. Cancer cells and normal breast tissues produce different signals. A handheld probe is applied to a small area of the lumpectomy specimen and analyzes whether the tissue is likely malignant or benign. The device gives a positive or negative reading for each touch. If any touch on a particular margin gives a positive reading, the margin is considered to be positive, and more tissue should be re-excised if possible. The device can only be used on the main lumpectomy specimen; it cannot be used on shavings or in the lumpectomy cavity of the patient's breast. Use of MarginProbe is intended to increase the probability that the surgeon will achieve clear margins in the initial surgery, thus avoiding the need for a second procedure to excise more breast tissue. However, disadvantages of this device include cost (of the console and the disposable probes) and the lack of evidence.

Situación reglamentaria

In December 2012, MarginProbe^® (Dilon Medical Technologies, formerly Dune Medical Devices, Caesarea, Israel) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process as an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤1 mm) of the main ex vivo lumpectomy specimen after primary excision (P110014). It is indicated for intraoperative use in conjunction with standard methods (eg, intraoperative imaging and palpation) for patients undergoing lumpectomy for previously diagnosed breast cancer. FDA product code: OEE.

In September 2025, the next-generation MarginProbe^® 2.0 was approved by the FDA through a premarket approval supplement (P110014/S013). The company announced the forthcoming U.S. commercial launch on December 15, 2025. The updated system uses a multiple array technology with multiple sensors to boost sensitivity.

Fundamento

Summary of evidence

For individuals who have localized breast cancer or DCIS undergoing breast-conserving surgery (lumpectomy) who receive handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins (e.g., MarginProbe), the evidence includes a randomized trial, several historical control studies, and a systematic review. Relevant outcomes are change in disease status and morbid events. In the randomized trial, histologic examination of surgical margins was not used in the control arm; the outcome measure (complete surgical resection) was not directly clinically relevant and was biased against the control arm; and patient follow-up was insufficient to assess local recurrence rates. The difference in re-excision rates between the 2 trial arms was not statistically significant. Diagnostic characteristics of the device showed only moderate sensitivity and poor specificity; thus, the device will miss some cancers and provide frequent false-positive results. Although several historical control studies have shown lower re-excision rates among patients in whom MarginProbe was used, the studies lacked adequate rigor to demonstrate whether the outcomes are attributable to MarginProbe. The studies did not report recurrence outcomes, which is important for assessing adequacy of resection. A randomized trial that assesses recurrence rates is required to evaluate whether the net health outcome improves with handheld radiofrequency spectroscopy compared with standard intraoperative surgical margin evaluation, including histologic techniques. No evaluable data for MarginProbe 2.0 were identified. La evidencia es insuficiente para determinar los efectos de esta tecnología en los resultados de salud.

Definiciones

N/D

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios del miembro, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: Es posible que esta lista de códigos no sea exhaustiva y que los códigos estén sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Bajo investigación; por lo tanto, no se cubre:

Referencias

1. Maloney BW, McClatchy DM, Pogue BW, et al. Review of methods for intraoperative margin detection for breast conserving surgery. J Biomed Opt. Oct 2018; 23(10): 1-19. PMID 30369108
2. Schnabel F, Boolbol SK, Gittleman M, et al. A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol. Mayo de 2014; 21(5): 1589-95. PMID 24595800
3. Rivera RJ, Holmes DR, Lara J. Analysis of the Impact of Intraoperative Margin Assessment with Adjunctive Use of MarginProbe versus Standard of Care on Tissue Volume Removed. Int J Surg Oncol. 2012; 2012: 868623. PMID 23326653
4. Administración de Medicamentos y Alimentos (FDA) de los EE. UU. Summary of Safety and Effectiveness Data (SSED): MarginProbe System. 2012
5. Allweis TM, Kaufman Z, Lelcuk S, et al. A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery. Am J Surg. Oct 2008; 196(4): 483-9. PMID 18809049
6. Geha RC, Taback B, Cadena J, et al. A single institution's randomized double-arm prospective study of lumpectomy margins with adjunctive use of the MarginProbe in nonpalpable breast cancers. Breast J. Nov 2020; 26(11): 2157-2162. PMID 32772474
7. 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
8. St John ER, Al-Khudairi R, Ashrafian H, et al. Diagnostic Accuracy of Intraoperative Techniques for Margin Assessment in Breast Cancer Surgery: A Meta-analysis. Ann Surg. Feb 2017; 265(2): 300-310. PMID 27429028
9. Gray RJ, Pockaj BA, Garvey E, et al. Intraoperative Margin Management in Breast-Conserving Surgery: A Systematic Review of the Literature. Ann Surg Oncol. Jan 2018; 25(1): 18-27. PMID 28058560
10. Thill M, Dittrmer C, Baumann K, et al. MarginProbe(R)--final results of the German post-market study in breast conserving surgery of ductal carcinoma in situ. Breast. Feb 2014; 23(1): 94-6. PMID 24291375
11. Thill M, Röder K, Diedrich K, et al. Intraoperative assessment of surgical margins during breast conserving surgery of ductal carcinoma in situ by use of radiofrequency spectroscopy. Breast. Dec 2011; 20(6): 579-80. PMID 21885281
12. Sebastian M, Akbari S, Anglin B, et al. The impact of use of an intraoperative margin assessment device on re-excision rates. Springerplus. 2015; 4: 198. PMID 26020017
13. Blohmer JU, Tanko J, Kueper J, et al. MarginProbe(C) reduces the rate of re-excision following breast conserving surgery for breast cancer. Arch Gynecol Obstet. Agosto de 2016; 294(2): 361-7. PMID 26796680
14. Coble J, Reid V. Achieving clear margins. Directed shaving using MarginProbe as compared to a full cavity shave approach. Am J Surg. Apr 2017; 213(4): 627-630. PMID 28049561
15. Kupstas A, Ibrar W, Hayward RD, et al. A novel modality for intraoperative margin assessment and its impact on re-excision rates in breast conserving surgery. Am J Surg. Mar 2018; 215(3): 400-403. PMID 29191356
16. Gooch JC, Yoon E, Chun J, et al. The Relationship of Breast Density and Positive Lumpectomy Margins. Ann Surg Oncol. Jun 2019; 26(6): 1729-1736. PMID 30888516
17. Lee Van E, Ho BT, Seto S, et al. Use of MarginProbe as an adjunct to standard operating procedure does not significantly reduce re-excision rates in breast conserving surgery. Breast Cancer Res Treat. Aug 2020; 183(1): 145-151. PMID 32607640
18. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version.1.2026
19. American Society of Breast Surgeons. Performance and Practice Guidelines for Breast-Conserving Surgery. Partial Mastectomy. 2024
20. Chagpar, AB. Techniques to reduce positive margins in breast-conserving surgery. UpToDate. Updated Jun 12, 2024. Literature review through Jan 2026.
21. Wang J, Zhang L, Pan Z. Evaluating the impact of radiofrequency spectroscopy on reducing reoperations after breast conserving surgery: A meta-analysis. Jt Buon. Cancer. 2023;14(16):1413-1419 PMID: 37073138
22. Morrow M, Van Zee KJ, Solin LJ, et al. Society of Surgical Oncology-American Society for Radiation Oncology-American Society of Clinical Oncology Consensus Guideline on Margins for Breast-Conserving Surgery With Whole-Breast Irradiation in Ductal Carcinoma In Situ. J Clin Oncol. 2016;34(33):4040-4046. PMID: 27528719
23. Moran MS, Schnitt SJ, Giuliano AE, et al. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. J Clin Oncol. 2014;32(14):1507-1515 PMID: 24516019