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Novel Cavity Marking for Breast Cancer Surgery

This study is testing a new way to mark the surgical area (cavity) during breast conservation surgery for breast cancer or DCIS (Ductal Carcinoma in Situ). The goal is to help doctors more accurately identify the cavity margins for radiation therapy planning and delivery, and for any necessary re-excisions. You could be eligible if you are an adult aged 18 or older with a diagnosis of DCIS or invasive breast cancer (Tis-T3N0-3M0) and are planning to have or have had breast conservation surgery with oncoplastic reconstruction. The study will measure how confident doctors are in identifying the cavity after this new marking technique, within 8 weeks of surgery or after chemotherapy.

Study design
This interventional study plans to enroll 50 participants. It is not specified if it is randomized or blinded.
What's involved
All participants will have a novel cavity marking technique performed during their breast conservation surgery. Your confidence in cavity identification will be rated within 8 weeks of surgery or after chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, confidence rating in cavity identification, is measured within 8 weeks of surgery or within 8 weeks following adjuvant chemotherapy (~4-6 months after surgery).

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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

Recruiting
NAAges 18+InterventionalTreatment
University of Florida
~50 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:Novel cavity marking technique

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Confidence rating in cavity identification
Measured over Within 8 weeks of surgery if patient does not receive adjuvant chemotherapy or within 8 weeks following adjuvant chemotherapy (~4-6 months after surgery

Conditions

Ductal Carcinoma in Situ
Breast Cancer

Explore related trials

Breast CarcinomaBreast Ductal Carcinoma In Situ

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Lisa Spiguel, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Stephanie Portillo
[email protected]
352-273-3650
Email the study team

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Eligibility criteria

Inclusion

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
Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician or approved by the PI\] may be included).
Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy during surgery and radiation therapy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during the surgery and radiation portions of the trial and the potential risk factors for an unintentional pregnancy. SOCBP includes any subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as amenorrhea that has lasted for ≥ 12 consecutive months without another cause.

Exclusion

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.
Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detailed for treatment of either a psychiatric or physical illness.

What this trial measures

  • Confidence rating in cavity identificationWithin 8 weeks of surgery if patient does not receive adjuvant chemotherapy or within 8 weeks following adjuvant chemotherapy (~4-6 months after surgery

    Determine the percentage of patients that receive each of three possible confidence ratings ("Confident", "Informative", and "Ambiguous") from radiation oncologists for their confidence in being able to identify the surgical cavity on imaging.