Clinical trial · Observational
Digital Breast Tomosynthesis (DBT) to Improve Assessment of Resection Margins in Invasive Breast Cancer
Optimal Imaging Methods to Reduce Repeat Surgery in Invasive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
| Margins of Excision | — | UNRESOLVED | — |
| Mastectomy, Segmental | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Positive resection margin(s) in the final histopathology
- timeFrame
- 7 workdays, time from primary breastconserving surgery to the time where the final histopathology result is available.
- description
- The number of patients with one or more positive resection margins in the final histopathology.
- measure
- Re-excision-rate during primary breast conserving surgery
- timeFrame
- 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
- description
- The number of patients that recieves further excision of the cavity wherefrom the breast tumor is resected, during the initial breast conserving surgery.
- measure
- Rate of repeat surgery
- timeFrame
- 3 weeks from primary breastconserving surgery, depending on the final histopathology result.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed women with biopsy-verified invasive breast cancer planned for breast conserving surgery. * Age \> 18 year Exclusion Criteria: * Previous surgery for pre-malignant or malignant lesions in the breast * Planned mastectomy
References
Publications (12)
- BACKGROUNDAmiel 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
- BACKGROUNDDeSnyder 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
- BACKGROUNDThill 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
- RESULTBodilsen 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
- RESULTSmitt 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
- RESULTJeevan 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
- RESULTBodilsen 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.