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
Conditions
Breast Cancer Screening - MRI Guided Breast Biopsy - Breast Cancer Diagnosis
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: IPBS
Type: Device
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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.
Locations
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Status: Recruiting
Contact: Colm Boylan, MD - 905-522-1155 - boylan@mcmaster.ca
Hopital du Saint-Sacrement
Quebec City, Quebec, Canada
Status: Recruiting
Contact: Nathalie Duchesne, B.Sc., M.D. F.R.C.P.C. - 418-473-6553 - nathalie.duchesne@me.com
Start Date
September 2013
Completion Date
September 2016
Sponsors
McMaster University
Source
McMaster University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page