Intraoperative Navigation for Surgically Precise Resection of the Chest (INSPIRE)

NCT ID: NCT04328584

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2025-11-30

Brief Summary

While undergoing chest wall resection, a surgeon's major concern is obtaining an appropriate surgical margin. Difficulty or failure to do so can result in prolonged operative time, need for re-operation due to a positive resection margin, or need for complex chest wall reconstruction due to unnecessarily wide resection. Over the last decades, surgical navigation systems have been developed to improve operative precision in various surgical fields. This is achieved by integrating patient images with intraoperative findings.

Detailed Description

Integration of CT imaging systems into the operating room now provide real-time 3D images of patient anatomy during surgery. This better adjusts for anatomical deformation and tissue excision compared to using preoperative images alone.

Twenty patients scheduled for chest wall resection will be enrolled over the study duration of 2 years. Patients will undergo imaging and surgery in the GTx-OR at Toronto General Hospital, as part of the GTx Program of the TECHNA Institute. All patients will be asked to consent to receiving their care in a research environment. They will also be asked to consent to having the intraoperative image acquired and used to generate a navigation view in the GTx-OR. Instead of resecting the chest wall lesion according to the preoperative images alone with intraoperative findings as per standard-care procedures, the navigation view will be used as an additional reference for surgeons during the operation.

Conditions

Thoracic Wall

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SNS

Intraoperative imaging/surgical navigation system (SNS)

Group Type: EXPERIMENTAL

surgical navigation system

Intervention Type: PROCEDURE

Navigation system providing surgeons with an additional view of the chest wall lesion

Interventions

surgical navigation system

Navigation system providing surgeons with an additional view of the chest wall lesion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Ability to provide informed consent

2. Scheduled to undergo surgical resection of a chest wall lesion

3. At least 18 years of age

4. Must sign and be given a copy of the written informed consent form

Exclusion Criteria

1. Unresectable lesions or unstable patient condition, for which surgery is not recommended

2. Participants with metallic implantation, such as ribs fixations, a pacemaker, or pedicle screws, which may affect the accuracy of CBCT

3. Excluded at the discretion of the clinical investigator/surgeon, if they are enrolled in other studies that will result in combined radiation exposure exceeding standard of care

4. Pregnant, lactating, or planning to become pregnant during the period of the evaluation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Judy McConnell

Role: CONTACT

judy.mcconnell@uhn.ca

4165817486

Facility Contacts

Judy McConnell

Role: primary

judy.mcconnell@uhn.ca

416-581-7486

Other Identifiers

18-6162

Identifier Type: -

Identifier Source: org_study_id