Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy

McMaster University

Status

Completed

Conditions

Breast Cancer Screening

Breast Cancer Diagnosis

MRI Guided Breast Biopsy

Treatments

Device: IPBS

Study type

Interventional

Funder types

Other

Identifiers

NCT01885741

IPBS-001

Details and patient eligibility

About

A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy procedures facilitated by the MRI-guided system. Patients will be followed after the procedure to assess clinical outcomes.

Enrollment

9 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female patients over the age of 18 with suspected or confirmed breast cancer requiring a manual MRI-guided breast biopsy for diagnosis and staging.
Individuals Capable of giving a free and informed consent.

Exclusion criteria

Any patient for whom the manual MRI-guided breast biopsy procedure would not be possible (size of patient, etc.).
Patients who refuse the procedure for any reason will be excluded from the study at the investigators discretion.
Patients who are not suitable for the procedure will be excluded at the investigators discretion.
Patients unwilling to complete associated study questionnaires or follow up visits.
Women who are pregnant or who plan to become pregnant within the study duration.