Status:

COMPLETED

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

Lead Sponsor:

McMaster University

Conditions:

Breast Cancer Screening

MRI Guided Breast Biopsy

Eligibility:

FEMALE

18+ years

Phase:

NA

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 facil...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2014

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT01885741

Start Date

September 1 2013

End Date

May 1 2014

Last Update

April 19 2017

Active Locations (2)

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Page 1 of 1 (2 locations)

1

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada, L8N 4A6

2

Hopital du Saint-Sacrement

Québec, Quebec, Canada, G1S 4L8