Cavity marking technique to improve radiotherapy planning after breast-conserving oncoplastic surgery
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
This will test a new cavity-marking method to help radiation teams plan treatment more accurately for adults having breast-conserving surgery with oncoplastic reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06903468 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with non‑invasive DCIS or invasive breast cancer undergoing or who have undergone breast-conserving surgery with oncoplastic reconstruction and ECOG performance status 0–1 are the intended candidates.
Not a fit: Patients having mastectomy, those not receiving radiotherapy, those with widespread metastatic disease, or with poor performance status are unlikely to benefit from this cavity-marking approach.
Why it matters
Potential benefit: If successful, the technique could improve radiation targeting and reduce unnecessary re‑excisions by more reliably identifying the surgical cavity and margins.
How similar studies have performed: Related approaches using surgical clips or radiopaque markers have improved cavity localization in prior work, but this specific oncoplastic-focused marking schema is novel and less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Spiguel, MD — University of Florida
- Study coordinator: Stephanie Portillo
- Email: portillos@ufl.edu
- Phone: 352-273-3650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.