MedTrace Logo

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

NCT06903468 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Lisa Spiguel, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2027-11-30
Completion
2029-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06903468 on ClinicalTrials.gov