Clinical trial NCT03734432: IGAR-Breast TeleOp Trial
Official title: IGAR-Breast Teleoperative Clinical Investigation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Diagnostic, Imaging, MRI
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
name: Sunnybrook Health Sciences Centre
First posted: 2018-11-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: ability for IGAR-Breast to perform breast biopsies teleoperatively
timeFrame: at time of sampling and pathological evaluation
Secondary outcomes:
measure: number and frequency of adverse events, device events and procedural deviations in addition to a comparison to results from previous trials for efficacy
timeFrame: During procedure
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Josephs Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Saint-Laurent
country: Canada
facility: Imagix - Radiologie Saint-Laurent
state: Quebec
Study officials:
affiliation: Csii/St Joseph's Healthcare Hamilton
name: Mehran Anvari
role: PRINCIPAL_INVESTIGATOR
References: