Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions

NANot yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

January 31, 2026

Study Completion Date

January 1, 2028

Conditions
Breast FibroadenomaAtypical Ductal HyperplasiaAtypical Lobular HyperplasiaLobular Carcinoma in SituFlat Epithelial AtypiaPhyllodes; FibroadenomaPhyllodes Breast TumorRadial ScarBreast PapillomaComplex Sclerosing Papillary Lesion of the Breast
Interventions
PROCEDURE

Vacuum-assisted percutaneous excision

The intervention group will undergo the vacuum assisted percutaneous excision (VAPE). All VAPE procedures will be performed on a digital supine table using the ATEC© Breast Biopsy System hand piece (Hologic) with a 9-gauge needle and a 10 or 20 mm aperture providing 6-mmHg of suction strength to completely excise the breast lesion.

PROCEDURE

Open surgical excision

The control group will undergo standard open surgical excision of the breast lesion. This will be done in the operating room using preoperative image-guided localization with radioactive seed (I-125) or in the procedure room of the Breast Care Centre if appropriate (i.e. lesion is palpable and localization is not required).

All Listed Sponsors
lead

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

NCT03868475 - Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions | Biotech Hunter | Biotech Hunter