Margin Intraoperative CT Feedback Feedback Study

NCT ID: NCT07242053

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-06
• Study Completion Date: 2026-03-01

Brief Summary

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.

Conditions

Lung Cancer (Diagnosis)

Study Design

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

Study Groups

Intraoperative CT of resected lung

Group Type: EXPERIMENTAL

Intraoperative CT of resected lung

Intervention Type: OTHER

Once the wedge resection is performed, the resected specimen will brought for CT scan

Interventions

Intraoperative CT of resected lung

Once the wedge resection is performed, the resected specimen will brought for CT scan

Intervention Type: OTHER

Eligibility Criteria

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.

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

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Kazuhiro Yasufuku

Dr. Kazuhiro Yasufuku

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UHN

Toronto, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

23-5750

Identifier Type: -

Identifier Source: org_study_id