Is 3D Modeling From Non-contrast CT Accurate for Minimally Invasive Lung Segmentectomies ? (3D-LS)

November 18, 2025 updated by: University Hospital, Strasbourg, France

To assess the RELIABILITY in terms of accuracy of 3D-CT and 2D-CT reconstructions compared to intraoperative data regarding bronchovascular anatomy and tumor location. 3D CT reconstruction (CT scan without contrast injection) with Innersight3D® is equivalent to 2D CT (CT scan with contrast injection) for planning a minimally invasive lung segmentectomy.

Evaluate the impact of 3D reconstruction (from a CT scan without injection of contrast agent) on intraoperative and postoperative results

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Strasbourg
      • Strasbourg, Strasbourg, France, 67091
        • Service Chirurgie Thoracique - CHU de Strasbourg - France
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierre-Emmanuel FALCOZ, MD, PhD
        • Sub-Investigator:
          • Alex FOURDRAIN, MD
        • Sub-Investigator:
          • Yaniss BELAROUSSI, MD
        • Sub-Investigator:
          • Chloé MOINET, Resident doctor

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

Sampling Method

Non-Probability Sample

Study Population

  • Adult patient ≥ 18 years
  • with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy.
  • Chest CT scan available without and then with contrast
  • Eligible for VATS or RATS segmentectomy based on respiratory explorations

Description

Inclusion Criteria:

  • Adult patient ≥ 18 years
  • Patient agreeing to participate in the study
  • Patient with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy.
  • Chest CT scan available without and then with contrast
  • Eligible for VATS or RATS segmentectomy based on respiratory explorations

Exclusion Criteria:

  • Patient refusal to participate in the study
  • Allergic reactions to radiographic contrast agents
  • History of ipsilateral cardiothoracic surgery
  • Open segmentectomy (thoracotomy)
  • Histology different from that of NSCLC
  • Inability to provide the subject with informed information (difficulty understanding the subject, insufficient command of French, etc.)
  • Pregnant or breastfeeding women
  • Severe cognitive impairment and/or suspicion of lack of compliance or adherence, in the investigator's judgment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clinical stage IA lung lesions & malignancy
Patient with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy, cf eligibility criteria
Diagnostic test: Thoraco-abdomino-pelvic CT scan without and with contrast injection.
Eligible patients undergo the usual preoperative procedure, including consultations and CT scan with and without contrast injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RELIABILITY of 3D-CT and 2D-CT reconstructions regarding bronchovascular anatomy and tumor location - composite 1
Time Frame: Immediately after surgery
Accuracy between predicted bronchovascular anatomy by 3D CT and 2D CT reconstruction compared to intraoperative observations
Immediately after surgery
RELIABILITY of 3D-CT and 2D-CT reconstructions regarding bronchovascular anatomy and tumor location - composite 2
Time Frame: Immediately after surgery
Accuracy between predicted tumor location by 3D CT and 2D CT reconstruction compared to intraoperative observations
Immediately after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

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 (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Estimated)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9776

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.

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