The Right Tools for Real-Time Margin Assessment in BCS


Margin positivity status

Margin positivity rates continue to be a significant clinical challenge in breast conserving surgery. Up to 20%1, 2 of breast cancer patients in North America who undergo breast conserving lumpectomy require secondary surgeries, due to malignant tissue identified in the surgical cavity1 .

Additional surgeries can result in multiple complications, such as discomfort, stress, and poor cosmetic results for the patient – as well as increased anesthesia time, delay in providing adjuvant therapy, increased medical costs3 , and risk of local recurrence 4-12.

SBI ALApharma Canada Inc. understands that a reduction in positive margin rates can be achieved through optimizing surgical procedures13.


An imprecise standard of care

Currently, breast conserving surgery relies on the surgeon visually and physically examining the surgical cavity and the removed cancer tissue.

As surgeons usually try to minimize the amount of tissue removed to preserve the appearance of the breast and cancer at the margins or in the cavity is not always obvious through standard intraoperative methods of assessment, there is a risk that residual disease will be left in surgical cavity after the surgery is complete14,15 .


Moving breast conserving surgery forward

SBI ALApharma Canada Inc.’s Phase III pivotal study evaluates a new method for surgeons to visualize carcinoma in real-time, both in the surgical cavity and on the margins of excised specimen(s) during the index breast conserving surgery procedure.

The use of the fluorescence imaging agent PD G 506 A with the Eagle V1.2 Imaging SystemTM  provides surgeons with a cutting-edge method for real-time intraoperative imaging of the breast surgical cavity and specimens. Since protoporphyrin IX (PpIX) fluorescence is expected to occur predominately in cancer cells16-18 , the use of this fluorescent agent with a fluorescence imaging system may improve the identification of surgical margins containing residual disease.

Improved visualization of cancer at the surgical margins, may result in more complete removal of cancerous tissues and better patient outcomes.

Th e Handheld Fluorescence Camera allows surgeons to visualize the presence of PpIX fluorescence within the surgical cavity and on margins of excised specimens during BCS,


1. Porter G, Wagar B, Bryant H, Hewitt M, Wai E, Dabbs K, McFarlane A and Rahal R. Rates of breast cancer surgery in Canada from 2007/08 to 2009/10: retrospective cohort study. CMAJ Open. 2014;2:E102-8.
2. Wilke LG, Czechura T, Wang C, Lapin B, Liederbach E, Winchester DP and Yao K. Repeat surgery after breast conservation for the treatment of stage 0 to II breast carcinoma: a report from the National Cancer Data Base, 2004-2010. JAMA Surg. 2014;149:1296-305.
3. Waljee JF, Hu ES, Newman LA and Alderman AK. Predictors of re-excision among women undergoing breast-conserving surgery for cancer. Ann Surg Oncol. 2008;15:1297-303.
4. Agostinho JL, Zhao X, Sun W, Laronga C, Kiluk JV, Chen DT and Lee MC. Prediction of positive margins following breast conserving surgery. Breast. 2015;24:46-50.
5. Porter G, Wagar B, Bryant H, Hewitt M, Wai E, Dabbs K, McFarlane A and Rahal R. Rates of breast cancer surgery in Canada from 2007/08 to 2009/10: retrospective cohort study. CMAJ Open. 2014;2:E102-8.
6. Parvez E, Hodgson N, Cornacchi SD, Ramsaroop A, Gordon M, Farrokhyar F, Porter G, Quan ML, Wright F and Lovrics PJ. Survey of American and Canadian general surgeons' perceptions of margin status and practice patterns for breast conserving surgery. The breast journal. 2014;20:481-8.
7. Biglia N, Ponzone R, Bounous VE, Mariani LL, Maggiorotto F, Benevelli C, Liberale V, Ottino MC and Sismondi P. Role of re-excision for positive and close resection margins in patients treated with breast-conserving surgery. Breast. 2014;23:870-5.
8. Wei S, Kragel CP, Zhang K and Hameed O. Factors associated with residual disease after initial breast-conserving surgery for ductal carcinoma in situ. Human pathology. 2012;43:986-93.
9. Lovrics PJ, Gordon M, Cornacchi SD, Farrokhyar F, Ramsaroop A, Hodgson N, Quan ML, Wright F and Porter G. Practice patterns and perceptions of margin status for breast conserving surgery for breast carcinoma: National Survey of Canadian General Surgeons. Breast. 2012;21:730-4.
10. Thill M, Roder K, Diedrich K and Dittmer C. Intraoperative assessment of surgical margins during breast conserving surgery of ductal carcinoma in situ by use of radiofrequency spectroscopy. Breast. 2011;20:579-80.
11. Hennigs A, Fuchs V, Sinn HP, Riedel F, Rauch G, Smetanay K, Golatta M, Domschke C, Schuetz F, Schneeweiss A, Sohn C and Heil J. Do Patients After Reexcision Due to Involved or Close Margins Have the Same Risk of Local Recurrence as Those After One-Step Breast-Conserving Surgery? Annals of Surgical Oncology. 2016;23:1831-1837.
12. Clough KB, Benyahi D, Nos C, Charles C and Sarfati I. Oncoplastic Surgery: Pushing the Limits of Breast- Conserving Surgery. The breast journal. 2015.
13. Pleijhuis RG, Graafland M, de Vries J, Bart J, de Jong JS and van Dam GM. Obtaining adequate surgical margins in breast-conserving therapy for patients with early-stage breast cancer: current modalities and future directions. Ann Surg Oncol. 2009;16:2717-30.
14. Ananthakrishnan P, Balci FL and Crowe JP. Optimizing surgical margins in breast conservation. Int J Surg Oncol. 2012;2012:585670.
15. Houssami N, Macaskill P, Marinovich ML, Dixon JM, Irwig L, Brennan ME and Solin LJ. Meta-analysis of the impact of surgical margins on local recurrence in women with early-stage invasive breast cancer treated with breast-conserving therapy. Eur J Cancer. 2010;46:3219-32.
16. Millon SR, Ostrander JH, Yazdanfar S, Brown JQ, Bender JE, Rajeha A and Ramanujam N. Preferential accumulation of 5-aminolevulinic acid-induced protoporphyrin IX in breast cancer: a comprehensive study on six breast cell lines with varying phenotypes. Journal of Biomedical Optics. 2010;15:018002.
17. Ladner DP, Steiner RA, Allemann J, Haller U and Walt H. Photodynamic diagnosis of breast tumours after oral application of aminolevulinic acid. Br J Cancer. 2001;84:33-7.
18. Frei KA, Bonel HM, Frick H, Walt H and Steiner RA. Photodynamic detection of diseased axillary sentinel lymph node after oral application of aminolevulinic acid in patients with breast cancer. Br J Cancer. 2004;90:805-9.

Interested in becoming
a clinical partner?

We are currently recruiting new clinical sites in the USA and Canada.

Are you a surgeon who performs breast-conserving lumpectomies at your institution?

Do you wish to learn more about this clinical trial? Please fill in your details here. Our clinical team will reach out to you about becoming a site with this Phase III clinical trial.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.