RecruitingNot ApplicableNCT06903468

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

Sponsor

University of Florida

Enrollment

50 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Ductal Carcinoma in Situ

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new technique for marking the surgical cavity in breast cancer patients after breast-conserving surgery with oncoplastic reconstruction, to improve the precision of radiation therapy targeting after surgery. **You may be eligible if...** - You are 18 or older - You have confirmed breast cancer (invasive or non-invasive, DCIS through T3, including spread to lymph nodes) - You are planning to have or have already had breast-conserving surgery with oncoplastic reconstruction and cavity marking - Your overall health is good to moderate (ECOG 0 or 1) - You do not have more than one active cancer at the time of enrollment **You may NOT be eligible if...** - You have had previous radiation to the same breast - You are pregnant or breastfeeding - You have inflammatory breast cancer - Your treating physician determines you are not a suitable candidate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENovel 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.

Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT06903468

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