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.
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer Screening, MRI Guided Breast Biopsy, Breast Cancer Diagnosis
Female
Breast Cancer Screening, MRI Guided Breast Biopsy, Breast Cancer Diagnosis
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images.
Outcome Time Frame:
Day 1
Safety Issue:
No
Authority:
Canada: Public Health Agency of Canada
Study ID:
IPBS-001
NCT ID:
NCT01885741
Start Date:
September 2013
Completion Date:
September 2015
Related Keywords:
- Breast Cancer Screening
- MRI Guided Breast Biopsy
- Breast Cancer Diagnosis
- Breast Neoplasms
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