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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
A 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.
University of Florida
Gainesville, Florida, United States
RECRUITINGConfidence 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.
Time frame: Within 8 weeks of surgery if patient does not receive adjuvant chemotherapy or within 8 weeks following adjuvant chemotherapy (~4-6 months after surgery
Percent of patients needing re-excision
Determine the percentage of patients needing re-excision
Time frame: 7-14 days post-surgery
Local disease recurrence rate
Determine the percentage of patients that have local disease recurrence at 2 years post-surgery
Time frame: 2 years post-surgery
Median overall survival rate
Determine the median overall survival rate at 2 years post-surgery.
Time frame: 2 years post-surgery
Median recurrence-free survival rate
Determine the median recurrence-free survival rate at 2 years post-surgery.
Time frame: 2 years post-surgery
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