IGAR-Breast TeleOp Trial

Breast Cancer Clinical Trial

— IGAR-Breast-TO  

Official title:

IGAR-Breast Teleoperative Clinical Investigation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03734432
• Other study ID #: IGAR-TO-007
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: McMaster University
• Contact: Karen Barlow
• Phone: 905-522-1155
• Email: kbarlow[@]stjoes.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	St. Josephs Healthcare Hamilton	Hamilton	Ontario
Canada	Imagix - Radiologie Saint-Laurent	Saint-Laurent	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	St. Joseph's Healthcare Hamilton, Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

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