Lung Cancer3D-LSNCT07234604
Is 3D Modeling From Non-contrast CT Accurate for Minimally Invasive Lung Segmentectomies ?
An observational study of Lung Cancer and Non-Small Cell Lung Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-Small Cell Lung Cancer
- What is being tested?
- Thoraco-abdomino-pelvic CT scan without and with contrast injection.
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service Chirurgie Thoracique - CHU de Strasbourg - France
Strasbourg, Strasbourg, 67091
Pierre-Emmanuel FALCOZ, MD, PhD, 33 3 69 55 08 54, pierre-emmanuel.falcoz@chru-strasbourg.fr
Chloé MOINET, Interne, 33 3 69 55 08 54, chloe.moinet@chru-strasbourg.fr
About this study
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
- Being tested
- Thoraco-abdomino-pelvic CT scan without and with contrast injection.
- Keywords
- Lung cancer, Segmentectomy, 3D reconstruction, Computed tomography, Minimally invasive surgery
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Thoraco-abdomino-pelvic CT scan without and with contrast injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234604
- Sponsor's protocol ID
- 9776
- Acronym
- 3D-LS
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is 3D Modeling From Non-contrast CT Accurate for Minimally Invasive Lung Segmentectomies ?
- ClinicalTrials.gov ID
- NCT07234604
- Acronym / sponsor ID
- 3D-LS / 9776
- Conditions
- Lung Cancer, Non-Small Cell Lung Cancer
- Keywords
- Lung cancer, Segmentectomy, 3D reconstruction, Computed tomography, Minimally invasive surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical stage IA lung lesions & malignancy | – | Diagnostic Test: Thoraco-abdomino-pelvic CT scan without and with contrast injection.Patient with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy, cf eligibility criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Clinical stage IA lung lesions & malignancy |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Non-Small Cell Lung Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Emmanuel FALCOZ, MD, PhD (33 3 69 55 08 54, pierre-emmanuel.falcoz@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RELIABILITY of 3D-CT and 2D-CT reconstructions regarding bronchovascular anatomy and tumor location - composite 1 (time frame: Immediately after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.