IGAR-Breast TeleOp Trial

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: IGAR-Breast TeleOp

• Registration Number: NCT03734432
• Lead Sponsor: McMaster University

Brief Summary

The aim of this study is to answer the question: can the IGAR-Breast safely and effectively perform teleoperative breast biopsies? This is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. In addition the number of adverse events, device events and procedural deviations will be assessed to determine safety and efficacy.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-06
• Last Update Submitted: 2018-11-06
• Study First Posted: 2018-11-08
• Last Update Posted: 2018-11-08
• Study Start: 2019-01-01
• Primary Completion: 2019-03-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	IGAR-Breast TeleOp	IGAR-Breast TeleOp

Primary Outcome Measures

Name	Time	Method
ability for IGAR-Breast to perform breast biopsies teleoperatively	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

Secondary Outcome Measures

Name	Time	Method
number and frequency of adverse events, device events and procedural deviations in addition to a comparison to results from previous trials for efficacy	During procedure	The number of times the local radiologist is required to participate will also be observed from a safety perspective

Trial Locations

Locations (3)

St. Josephs Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada

Imagix - Radiologie Saint-Laurent; 🇨🇦 Saint-Laurent, Quebec, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada