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

Thoracic Wall Clinical Trial

— INSPIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04328584
• Other study ID #: 18-6162
• Status: Recruiting
• Phase: N/A
• Start date: November 2024
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: University Health Network, Toronto
• Contact: Judy McConnell
• Phone: 4165817486
• Email: judy.mcconnell[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Wall

Intervention

Procedure:
• surgical navigation system
Navigation system providing surgeons with an additional view of the chest wall lesion

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance metrics for navigation-assisted chest wall resection		2 years
Secondary	Image accuracy metrics - Intraoperative CBCT and preoperative CT will be compared to confirm accuracy in predicting the anatomical relationship of lesions with adjacent structures.		2 years
Secondary	Incident reports of OR-related delays and malfunctions		2 years