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

Not Applicable

Completed

• Conditions: Breast Cancer Diagnosis; Breast Cancer Screening; MRI Guided Breast Biopsy
• Interventions: Device: IPBS

• Registration Number: NCT01885741
• Lead Sponsor: McMaster University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-25
• Study Start: 2013-09
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPBS	IPBS	-

Primary Outcome Measures

Name	Time	Method
Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images.	Day 1

Trial Locations

Locations (2)

Hopital du Saint-Sacrement; 🇨🇦 Quebec City, Quebec, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada