Lung Cancer (Diagnosis)NCT07242053
Margin Intraoperative CT Feedback Feedback Study
A study testing Intraoperative CT of resected lung in people with Lung Cancer (Diagnosis), run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis)
- What is being tested?
- Intraoperative CT of resected lung
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for wedge resection for lung malignancies (included suspected lesions).
- 18 years of age or older.
Who cannot join
- Any patients with inability to give informed consent
- Wedge resection for non-therapeutic purpose, e.g. diagnostic purpose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lung Cancer (Diagnosis)
- Being tested
- Intraoperative CT of resected lung
- Keywords
- Surgical Margins
- Medical subject headings
- Lung Neoplasms, Disease, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative CT of resected lungOther
Once the wedge resection is performed, the resected specimen will brought for CT scan
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative CT of resected lung | Experimental | Not described Receives: Other: Intraoperative CT of resected lung |
What is being measured
The primary outcome is the main question the study is designed to answer.
The contribution of intraoperative feedback to treatment decision, and its validity
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start6 Mar 2024
- Primary completion1 Aug 2025
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuhiro Yasufuku, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242053
- Sponsor's protocol ID
- 23-5750
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yanagihara T, Miura K, Bernards N, Kitazawa S, Yokote F, Nakahashi K, Fujibayashi Y, Hinokuma H, Sonoda D, Hayama N, Wakeam E, Donahoe L, Yeung J, Cypel M, De Perrot M, Pierre A, Waddell T, Keshavjee S, Cabanero M, Sato Y, Yasufuku K. Utility of Computed Tomography-Based Intraoperative Surgical Margin Evaluation in Wedge-Resected Lung Specimens. Eur J Cardiothorac Surg. 2026 Feb 5;68(2):ezag074. doi: 10.1093/ejcts/ezag074.
PubMed 41663896
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraoperative CT Feedback of Wedge Resected Lung for the Assessment of Surgical Margin
- ClinicalTrials.gov ID
- NCT07242053
- Acronym / sponsor ID
- 23-5750
- Conditions
- Lung Cancer (Diagnosis)
- Keywords
- Surgical Margins
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative CT of resected lung | Experimental | Other: Intraoperative CT of resected lung |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for wedge resection for lung malignancies (included suspected lesions).
- 18 years of age or older.
Key exclusion criteria (2 listed)
- Any patients with inability to give informed consent
- Wedge resection for non-therapeutic purpose, e.g. diagnostic purpose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative CT of resected lungOnce the wedge resection is performed, the resected specimen will brought for CT scan | Other | Intraoperative CT of resected lung |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 41663896Yanagihara T, Miura K, Bernards N, Kitazawa S, Yokote F, Nakahashi K, Fujibayashi Y, Hinokuma H, Sonoda D, Hayama N, Wakeam E, Donahoe L, Yeung J, Cypel M, De Perrot M, Pierre A, Waddell T, Keshavjee S, Cabanero M, Sato Y, Yasufuku K. Utility of Computed Tomography-Based Intraoperative Surgical Margin Evaluation in Wedge-Resected Lung Specimens. Eur J Cardiothorac Surg. 2026 Feb 5;68(2):ezag074. doi: 10.1093/ejcts/ezag074.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative CT of resected lung in people with Lung Cancer (Diagnosis), run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The contribution of intraoperative feedback to treatment decision, and its validity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07242053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.