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

University Health Network, Toronto

Status: Enrolling

Conditions: Thoracic Wall

Treatments: Procedure: surgical navigation system

Study type: Interventional

Funder types: Other

Identifiers

NCT04328584

18-6162

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

SNS

Experimental group

Description:

Intraoperative imaging/surgical navigation system (SNS)

Treatment:

Procedure: surgical navigation system