Cavity marking technique to improve radiotherapy planning after breast-conserving oncoplastic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial applies a novel surgical cavity-marking schema at the time of tumor resection and oncoplastic reconstruction to make the lumpectomy cavity more visible on CT simulation for radiotherapy planning. Markers placed according to the schema are used by radiation oncologists to delineate boost volumes and guide recommendations for re-excision when margins appear close or positive. The primary practical outcomes are accuracy of cavity localization on CT and concordance between recommended re-excisions and actual margin status. Eligible patients are adults with DCIS or invasive breast cancer (Tis-T3N0-3M0) who undergo breast conservation with oncoplastic reconstruction and have ECOG 0-1.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Lisa Spiguel, MD — University of Florida
• Study coordinator: Madeline Campellone
• Email: mcampellone@ufl.edu
• Phone: 352-273-5128

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.