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Margin Intraoperative CT Feedback Feedback Study

University Health Network, Toronto logo

University Health Network, Toronto

Status

Active, not recruiting

Conditions

Lung Cancer (Diagnosis)

Treatments

Other: Intraoperative CT of resected lung

Study type

Interventional

Funder types

Other

Identifiers

NCT07242053
23-5750

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Intraoperative CT of resected lung
Experimental group
Treatment:
Other: Intraoperative CT of resected lung

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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