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NCT Number: NCT07234604

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service Chirurgie Thoracique - CHU de Strasbourg - France

Strasbourg, 67091, France

Location contact

Alex FOURDRAIN, MD

SUB_INVESTIGATOR

Chloé MOINET, Interne

CONTACT

[email protected]

33 3 69 55 08 54

Chloé MOINET, Resident doctor

SUB_INVESTIGATOR

Pierre-Emmanuel FALCOZ, MD, PhD

CONTACT

[email protected]

33 3 69 55 08 54

Pierre-Emmanuel FALCOZ, MD, PhD

PRINCIPAL_INVESTIGATOR

Yaniss BELAROUSSI, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chloé Moinet, Resident doctor

CONTACT

[email protected]

33 3 69 55 08 54

Pierre-Emmanuel FALCOZ, MD, PhD

CONTACT

[email protected]

33 3 69 55 08 54

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: 3D-LS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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