NCT06903468

Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate a novel approach to marking surgical cavity margins following tumor resection, to allow for more accurate radiotherapy following oncoplastic surgery. Our proposed cavity marking schema will allow radiation oncology to identify the cavity margins more accurately on CT simulation for radiation planning and delivery. This cavity marking schema also provides more accurate margin identification in patients recommended for re-excision of close or positive margins.

Conditions

• Ductal Carcinoma in Situ
• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Novel cavity marking technique	A novel cavity marking technique will be performed on all participants during their breast conservation surgery. For this technique, cavity marking will be in a clockwise fashion per breast starting with the superior margin of the tumor bed. The superior margin of the left breast will be marked with a single large clip, followed by a double clip for the lateral margin, a triple clip for the inferior margin, and a quadruple clip for the medial margin. The superior margin of the right breast will be marked with a single large clip, followed by a double clip for the medial margin, a triple clip for the inferior margin and a quadruple clip for the lateral margin. Margins with multiple clips will always have one large clip with the remaining clips standard medium size.

Timeline

• Start date: 2025-10-27
• Primary completion: 2027-11-01
• Completion: 2029-11-01
• First posted: 2025-03-30
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States