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

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: Non-Small Cell Lung Cancer; Lung Cancer
• Intervention / Treatment: Diagnostic test: Thoraco-abdomino-pelvic CT scan without and with contrast injection.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Pierre-Emmanuel FALCOZ, MD, PhD; Phone Number: 33 3 69 55 08 54; Email: pierre-emmanuel.falcoz@chru-strasbourg.fr
• Study Contact Backup: Name: Chloé Moinet, Resident doctor; Phone Number: 33 3 69 55 08 54; Email: chloe.moinet@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg
    • Strasbourg, Strasbourg, France, 67091
      • Service Chirurgie Thoracique - CHU de Strasbourg - France
      • Contact: Pierre-Emmanuel FALCOZ, MD, PhD; Phone Number: 33 3 69 55 08 54; Email: pierre-emmanuel.falcoz@chru-strasbourg.fr
      • Contact: Chloé MOINET, Interne; Phone Number: 33 3 69 55 08 54; Email: chloe.moinet@chru-strasbourg.fr
      • 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

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

How is the study designed?

Number of groups / cohorts

1

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	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	Accuracy between predicted tumor location by 3D CT and 2D CT reconstruction compared to intraoperative observations	Immediately after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

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: Computed tomography; Lung cancer; Minimally invasive surgery; Segmentectomy; 3D reconstruction
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• 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