- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07242053
Margin Intraoperative CT Feedback Feedback Study
April 27, 2026 updated by: Kazuhiro Yasufuku, University Health Network, Toronto
Efficacy of Intraoperative CT Feedback of Wedge Resected Lung for the Assessment of Surgical Margin
To date, there is no established method for confirming whether sufficient margins have been obtained during surgery, only post-surgery by a pathologist.
The purpose of this study is to evaluate the impact of intraoperative CT margin feedback on surgical decisions, such as additional removal.
The ability to accurately evaluate surgical margins intraoperatively could reduce the risk of locoregional recurrence and eliminate the need for additional treatment after surgery.
Moreover, optimal intraoperative feedback to surgeon could influence surgical decision making and contribute to the satisfactory outcome.
This is a single center clinical trial.
A total of 80 patients scheduled for wedge resections for lung malignancies (including suspected patients) will be enrolled in this study.
Nine surgeons in the division of thoracic surgery will also be involved as participants.
Once the wedge resection is performed, the resected specimen will be inflated and scanned by CT to measure surgical margin intraoperatively.
Surgeons will have access to the CT data and the associated margin data immediately.
They then may decide if an additional resection is required.
The expected margin surveyed by questionnaire will be compared to CT measured margin, and CT measured margin will be compared to pathological margin questionnaires over course.
After the total course of surgery, surgeons will be asked to complete a questionnaire as well to assess the satisfaction by intraoperative feedback.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1L7
- UHN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients scheduled for wedge resection for lung malignancies (included suspected lesions).
- 18 years of age or older.
Exclusion Criteria:
- Any patients with inability to give informed consent
- Wedge resection for non-therapeutic purpose, e.g. diagnostic purpose.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intraoperative CT of resected lung
|
Once the wedge resection is performed, the resected specimen will brought for CT scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The contribution of intraoperative feedback to treatment decision, and its validity
Time Frame: 2 years
|
After the total course of surgery, we will ask each surgeon individually for questionnaire 3 after feedback of the individual result of this study to assess the satisfaction by intraoperative feedback.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2024
Primary Completion (Actual)
August 1, 2025
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
September 30, 2025
First Submitted That Met QC Criteria
November 18, 2025
First Posted (Actual)
November 21, 2025
Study Record Updates
Last Update Posted (Actual)
April 28, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-5750
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.