Back to resultsStudy 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
Primary Purpose
Breast Cancer Screening, MRI Guided Breast Biopsy, Breast Cancer Diagnosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
IPBS
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer Screening
Eligibility 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.
Sites / Locations
- St. Joseph's Healthcare Hamilton
- Hopital du Saint-Sacrement
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IPBS
Arm Description
Outcomes
Primary Outcome Measures
Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01885741
Brief Title
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
Official Title
A Prospective, Open-Label, Single-Arm, Single-Site, 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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Screening, MRI Guided Breast Biopsy, Breast Cancer Diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPBS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
IPBS
Primary Outcome Measure Information:
Title
Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images.
Time Frame
Day 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Hopital du Saint-Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
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
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