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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida

About this trial

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 criteria

Qualifiers

Adults ≥ 18 years of age.

A pathological diagnosis consistent with non-invasive ductal carcinoma in-situ (DCIS) and invasive breast cancer, Tis-T3N0-3M0

Subject is planning to undergo or has undergone breast conservation surgery and oncoplastic reconstruction with cavity marking surgery.

ECOG Performance status of 0-1

Disqualifiers

Patient not recommended for, or have declined, adjuvant radiotherapy

Subjects with prior ipsilateral breast surgery and identifiable surgical clips.

Subjects who are confirmed to be pregnant or breastfeeding.

History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.

Trial design

Treatments tested in this trial

  • Novel cavity marking technique

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators