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

NCT ID: NCT07234604

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-01

Brief Summary

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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

Detailed Description

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Conditions

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Lung Cancer Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service Chirurgie Thoracique - CHU de Strasbourg - France

Strasbourg, Strasbourg, France

Site Status

Countries

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France

Central Contacts

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Pierre-Emmanuel FALCOZ, MD, PhD

Role: CONTACT

33 3 69 55 08 54

Chloé Moinet, Resident doctor

Role: CONTACT

33 3 69 55 08 54

Facility Contacts

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Pierre-Emmanuel FALCOZ, MD, PhD

Role: primary

33 3 69 55 08 54

Chloé MOINET, Interne

Role: backup

33 3 69 55 08 54

Other Identifiers

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9776

Identifier Type: -

Identifier Source: org_study_id

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