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.
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
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.
Single group
Novel cavity marking technique
Procedure/SurgeryA novel cavity marking technique will be performed on all participants during their breast conservation surgery. For this technique, cavity marking will be in a clockwise fashion per breast starting with the superior margin of the tumor bed. The superior margin of the left breast will be marked with a single large clip, followed by a double clip for the lateral margin, a triple clip for the inferior margin, and a quadruple clip for the medial margin. The superior margin of the right breast will be marked with a single large clip, followed by a double clip for the medial margin, a triple clip for the inferior margin and a quadruple clip for the lateral margin. Margins with multiple clips will always have one large clip with the remaining clips standard medium size.
Confidence rating in cavity identification
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.
Percent of patients needing re-excision
Determine the percentage of patients needing re-excision
Local disease recurrence rate
Determine the percentage of patients that have local disease recurrence at 2 years post-surgery
Median overall survival rate
Determine the median overall survival rate at 2 years post-surgery.
Median recurrence-free survival rate
Determine the median recurrence-free survival rate at 2 years post-surgery.
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