Actively Recruiting
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
Led by University of Florida · Updated on 2025-12-15
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new technique for marking the surgical cavity after tumor removal in breast cancer patients undergoing breast conservation surgery with oncoplastic reconstruction. This approach aims to improve the accuracy of identifying cavity margins on CT scans used for planning and delivering radiotherapy. The marking system may also help determine precise margins for patients who need additional surgery due to close or positive margins. The study involves using a novel cavity marking technique during surgery, where clips are placed in a specific clockwise pattern around the tumor bed to mark the cavity margins. The marking differs slightly between the left and right breasts but consistently includes one large clip and several medium-sized clips placed at defined positions. This procedure is performed on all participants during their breast conservation surgery. Participants will be followed to evaluate how confident clinicians are in identifying the cavity on imaging within 8 weeks after surgery or chemotherapy. Researchers will also track the percentage of patients needing additional surgery within 7 to 14 days after the initial surgery and monitor local disease recurrence, overall survival, and recurrence-free survival rates up to 2 years post-surgery. Throughout the study, participants will undergo assessments related to imaging and clinical outcomes to determine the usefulness of the cavity marking technique.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 63 18 years of age
- Pathological diagnosis of non-invasive ductal carcinoma in-situ (DCIS) or invasive breast cancer, Tis-T3N0-3M0
- Planning to undergo or have undergone breast conservation surgery with oncoplastic reconstruction including cavity marking
- ECOG performance status of 0 or 1
- Able to provide written informed consent and comply with study procedures
- No more than one active malignancy at enrollment (exceptions allowed per physician approval)
- If of childbearing potential, using adequate contraception and advised to avoid pregnancy during surgery and radiotherapy
You will not qualify if you...
- Not recommended for or declined adjuvant radiotherapy
- Prior ipsilateral breast surgery with identifiable surgical clips
- Confirmed pregnancy or breastfeeding
- Any disease or condition that contraindicates study therapy or might affect results or increase risk, as judged by physician
- Prisoners, involuntarily incarcerated, or under compulsory treatment for psychiatric or physical illness
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo breast conservation surgery with oncoplastic reconstruction including the novel cavity marking technique.
1 surgical visit (in-person)
Duration - 7 to 14 days post-surgery
Participants are monitored for the need of re-excision and recovery after surgery.
1 follow-up visit (in-person)
Duration - Approximately 4 to 6 months depending on chemotherapy schedule
Participants receive adjuvant radiotherapy following surgery with cavity marking.
Visits scheduled according to radiotherapy and chemotherapy treatment plan
Duration - Up to 2 years post-surgery
Participants are monitored for local disease recurrence and overall survival outcomes.
Periodic visits for up to 2 years
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
S
Stephanie Portillo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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