Clinical trial NCT04328584: Intraoperative Navigation for Surgically Precise Resection of the Chest (INSPIRE)
Official title: Intraoperative Navigation for Surgically Precise Resection of the Chest (INSPIRE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Wall
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Performance metrics for navigation-assisted chest wall resection
timeFrame: 2 years
Secondary outcomes:
measure: Image accuracy metrics - Intraoperative CBCT and preoperative CT will be compared to confirm accuracy in predicting the anatomical relationship of lesions with adjacent structures.
timeFrame: 2 years
measure: Incident reports of OR-related delays and malfunctions
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References: