Digital Breast Tomosynthesis (DBT) to Improve Assessment of Resection Margins in Invasive Breast Cancer

NCT04478669 | Completed

• 1 other identifier: 1107210020
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The challenge of breast conserving surgery (BCS) is to obtain free resection margins, by removing the invasive tumor and the precursor cells: DCIS (Ductal Carcinoma in Situ). Consequently, 17%-25% of primary invasive breast cancer patients will need a repeat surgery. Repeat breast surgery has been associated with higher surgical risks, poorer cosmetic outcome and increased psychological and economic burden. Finding a precise method to obtain tumor- and DCIS-free resection margins during BCS is therefore strongly needed. The purpose with this study is to investigate if the need for a re-operation can be reduced by performing Digital Breast Tomosynthesis (DBT) of the resected tumor margins compared to the currently used standard X-ray during BCS.

Conditions

Invasive Breast Cancer; Mastectomy, Segmental; Margins of Excision

Keywords

Digital breast tomosynthesis; Diagnostic imaging

Outcome Measures

Primary Outcomes (3)

• Positive resection margin(s) in the final histopathology

  The number of patients with one or more positive resection margins in the final histopathology.

  7 workdays, time from primary breastconserving surgery to the time where the final histopathology result is available.

• Re-excision-rate during primary breast conserving surgery

  The number of patients that recieves further excision of the cavity wherefrom the breast tumor is resected, during the initial breast conserving surgery.

  One workday, time from primary breastconserving surgery to the time where data of the re-excision of the cavity during same surgery is available in the patient electronical journal

• Rate of repeat surgery

  The number of patients that recieves a second or a third surgery due to insufficient resection margins during initial primary breast conserving surgery.

  3 weeks from primary breastconserving surgery, depending on the final histopathology result.

Secondary Outcomes (3)

• Diagnostic performance of the tested method to predict correct resection margins status.

  one year from primary breast conserving surgery, when the inclusion of all patients is final and the dataanalysis is ready.

• Weight of the re-excised breast tumor during initial breast conserving surgery

  One work day, The weight will be registered during the day the patient recieves primary breast conserving surgery and will be registered by the surgeon in the patient electronical journal.

• Type of repeat surgery (both secondary and if any tertiar surgery)

  3 weeks from the primary breastconserving surgery, depending on the final histopathology result and what type of repeat surgery the patient is planned to recieve

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study participants will be recruited at the Department of Plastic and Breast Surgery at Aarhus University Hospital after they have been diagnosed with operable invasive breast cancer and scheduled for breast conserving surgery.

You may qualify if:

• Newly diagnosed women with biopsy-verified invasive breast cancer planned for breast conserving surgery.
• Age \> 18 year

You may not qualify if:

• Previous surgery for pre-malignant or malignant lesions in the breast
• Planned mastectomy

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Department og Plastic- and Breast Surgery

Aarhus, Danmark, 8200, Denmark

Location

Related Publications (12)

• Amiel CR, Fisher HM, Carver CS, Antoni MH. The importance of stress management among postresection breast cancer patients. Future Oncol. 2016 Dec;12(24):2771-2774. doi: 10.2217/fon-2016-0442. Epub 2016 Oct 19. No abstract available.

  PMID: 27756150 BACKGROUND

• DeSnyder SM, Hunt KK, Dong W, Smith BD, Moran MS, Chavez-MacGregor M, Shen Y, Kuerer HM, Lucci A. American Society of Breast Surgeons' Practice Patterns After Publication of the SSO-ASTRO-ASCO DCIS Consensus Guideline on Margins for Breast-Conserving Surgery With Whole-Breast Irradiation. Ann Surg Oncol. 2018 Oct;25(10):2965-2974. doi: 10.1245/s10434-018-6580-9. Epub 2018 Jul 9.

  PMID: 29987598 BACKGROUND

• Thill M, Baumann K, Barinoff J. Intraoperative assessment of margins in breast conservative surgery--still in use? J Surg Oncol. 2014 Jul;110(1):15-20. doi: 10.1002/jso.23634. Epub 2014 May 24.

  PMID: 24863286 BACKGROUND

• Bodilsen A, Bjerre K, Offersen BV, Vahl P, Amby N, Dixon JM, Ejlertsen B, Overgaard J, Christiansen P. Importance of margin width in breast-conserving treatment of early breast cancer. J Surg Oncol. 2016 May;113(6):609-15. doi: 10.1002/jso.24224. Epub 2016 Mar 16.

  PMID: 26991020 RESULT

• Smitt MC, Nowels K, Carlson RW, Jeffrey SS. Predictors of reexcision findings and recurrence after breast conservation. Int J Radiat Oncol Biol Phys. 2003 Nov 15;57(4):979-85. doi: 10.1016/s0360-3016(03)00740-5.

  PMID: 14575828 RESULT

• Jeevan R, Cromwell DA, Trivella M, Lawrence G, Kearins O, Pereira J, Sheppard C, Caddy CM, van der Meulen JH. Reoperation rates after breast conserving surgery for breast cancer among women in England: retrospective study of hospital episode statistics. BMJ. 2012 Jul 12;345:e4505. doi: 10.1136/bmj.e4505.

  PMID: 22791786 RESULT

• Bodilsen A, Bjerre K, Offersen BV, Vahl P, Ejlertsen B, Overgaard J, Christiansen P. The Influence of Repeat Surgery and Residual Disease on Recurrence After Breast-Conserving Surgery: A Danish Breast Cancer Cooperative Group Study. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S476-85. doi: 10.1245/s10434-015-4707-9. Epub 2015 Jul 16.

  PMID: 26178760 RESULT

• McCahill LE, Single RM, Aiello Bowles EJ, Feigelson HS, James TA, Barney T, Engel JM, Onitilo AA. Variability in reexcision following breast conservation surgery. JAMA. 2012 Feb 1;307(5):467-75. doi: 10.1001/jama.2012.43.

  PMID: 22298678 RESULT

• Hisada T, Sawaki M, Ishiguro J, Adachi Y, Kotani H, Yoshimura A, Hattori M, Yatabe Y, Iwata H. Impact of intraoperative specimen mammography on margins in breast-conserving surgery. Mol Clin Oncol. 2016 Sep;5(3):269-272. doi: 10.3892/mco.2016.948. Epub 2016 Jul 4.

  PMID: 27588192 RESULT

• Ramos M, Diaz JC, Ramos T, Ruano R, Aparicio M, Sancho M, Gonzalez-Orus JM. Ultrasound-guided excision combined with intraoperative assessment of gross macroscopic margins decreases the rate of reoperations for non-palpable invasive breast cancer. Breast. 2013 Aug;22(4):520-4. doi: 10.1016/j.breast.2012.10.006. Epub 2012 Oct 27.

  PMID: 23110817 RESULT

• McClatchy DM 3rd, Zuurbier RA, Wells WA, Paulsen KD, Pogue BW. Micro-computed tomography enables rapid surgical margin assessment during breast conserving surgery (BCS): correlation of whole BCS micro-CT readings to final histopathology. Breast Cancer Res Treat. 2018 Dec;172(3):587-595. doi: 10.1007/s10549-018-4951-3. Epub 2018 Sep 17.

  PMID: 30225621 RESULT

• Park KU, Kuerer HM, Rauch GM, Leung JWT, Sahin AA, Wei W, Li Y, Black DM. Digital Breast Tomosynthesis for Intraoperative Margin Assessment during Breast-Conserving Surgery. Ann Surg Oncol. 2019 Jun;26(6):1720-1728. doi: 10.1245/s10434-019-07226-w. Epub 2019 Mar 14.

  PMID: 30877499 RESULT

MeSH Terms

Conditions

Margins of Excision

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Peer Christiansen, DMSc, Prof.

  Department of Plastic and Breast Surgery, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student, radiologist

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: September 17, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

DK (1)