IGAR-Breast TeleOp Trial

NCT03734432 | Unknown DMC

• 1 other identifier: IGAR-TO-007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

Diagnostic, Imaging, MRI

Outcome Measures

Primary Outcomes (1)

• ability for IGAR-Breast to perform breast biopsies teleoperatively

  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 Outcomes (1)

• 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

Study Arms (1)

Patients

EXPERIMENTAL

IGAR-Breast TeleOp

Device: IGAR-Breast TeleOp

Interventions

IGAR-Breast TeleOp DEVICE

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (3)

St. Josephs Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Imagix - Radiologie Saint-Laurent

Saint-Laurent, Quebec, H4R 0B7, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehran Anvari

  Csii/St Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Barlow

CONTACT

905-522-1155; kbarlow@stjoes.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 8, 2018
• Study Start: January 1, 2019
• Primary Completion: March 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 8, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)