IGAR-Breast TeleOp Trial (IGAR-Breast-TO)
IGAR-Breast Teleoperative Clinical Investigation
Study Overview
Detailed Description
In this prospective clinical trial, patients who present to the breast cancer clinic at one of the primary sites with suspected breast cancer requiring MRI-guided biopsy for diagnosis or staging will be screened consecutively. Patients who meet the inclusion criteria will be approached for consent to participate in the study. Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site. All consenting participants will be followed up for the assessment of the secondary outcome measure.
A total of 5-10 participants will be consented for the pilot investigation.
Each individual subject's participation is estimated to last approximately one week post procedure, with the trial itself expected to be completed within one year of its start date.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Josephs Healthcare Hamilton
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Quebec
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Saint-Laurent, Quebec, Canada, H4R 0B7
- Imagix - Radiologie Saint-Laurent
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female subjects aged ≥ 18 years who require MRI-guided breast biopsy for diagnosis and/or staging Subjects are able to tolerate procedures for the MRI
Exclusion Criteria:
- Subjects who refuse or are unable to give free and informed consent Subjects requiring more than one breast biopsy Subjects with breast implants or other foreign bodies Subjects for whom investigator determines IGAR-Breast enabled MRI-guided breast biopsy is not possible (size of subject, location of lesion, size of breast, etc.) Subjects who are pregnant or who plan to become pregnant during the course of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients
IGAR-Breast TeleOp
|
Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ability for IGAR-Breast to perform breast biopsies teleoperatively
Time Frame: at time of sampling and pathological evaluation
|
analyzing the frequency of successful biopsy, in which the samples collected are of diagnostic quality as determined by radiologist
|
at time of sampling and pathological evaluation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number and frequency of adverse events, device events and procedural deviations in addition to a comparison to results from previous trials for efficacy
Time Frame: During procedure
|
The number of times the local radiologist is required to participate will also be observed from a safety perspective
|
During procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehran Anvari, Csii/St Joseph's Healthcare Hamilton
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IGAR-TO-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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