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

NCT07234604 | Not Yet Recruiting

• 1 other identifier: 9776
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer; Non-Small Cell Lung Cancer

Keywords

Lung cancer; Segmentectomy; 3D reconstruction; Computed tomography; Minimally invasive surgery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Interventions

Thoraco-abdomino-pelvic CT scan without and with contrast injection. DIAGNOSTIC_TEST

Eligible patients undergo the usual preoperative procedure, including consultations and CT scan with and without contrast injection.

Clinical stage IA lung lesions & malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service Chirurgie Thoracique - CHU de Strasbourg - France

Strasbourg, Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Pierre-Emmanuel FALCOZ, MD, PhD

CONTACT

33 3 69 55 08 54; pierre-emmanuel.falcoz@chru-strasbourg.fr

Chloé Moinet, Resident doctor

CONTACT

33 3 69 55 08 54; chloe.moinet@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (1)