Predicting lung function impairment after surgery for lung cancer
Complication and Lung Function Impairment Prediction Using Perfusion and CT Air Trapping (CLIPPCAIR): Protocol for the Development and Validation of a Novel Algorithm for Post-resection Lung Function
University Hospital, Montpellier · NCT03885765
This study is trying to create a new tool to predict how well patients' lungs will work after surgery for lung cancer by looking at their CT scans and comparing it to older methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT03885765 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a new algorithm that predicts post-operative lung function, specifically forced expiratory volume in 1 second (FEV1), for patients undergoing lung resection due to non-small cell lung cancer. The algorithm will utilize data from thoracic CT scans with contrast media and will be compared to traditional scintigraphic data in high-risk patients. Additionally, the study will explore the relationship between pre-surgical imaging, post-surgical respiratory function changes, and health-related quality of life. The research will also assess the cumulative doses of contrast media and radiation associated with imaging procedures.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with non-small cell lung cancer who are scheduled for pulmonary excision surgery and have a recent CT scan.
Not a fit: Patients who are contraindicated for surgery or iodine injection, or those under legal protection, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of predicting lung function outcomes after surgery, leading to better patient management and surgical decision-making.
How similar studies have performed: While similar predictive models exist, this approach utilizing CT imaging data for lung function prediction is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient diagnosed with non-small cell lung cancer * Indication for pulmonary excision surgery * Patient requiring a more recent pre-surgical computed tomography scan (CT scan) * The patient has been correctly informed about the study and has signed the consent form * The patient is affiliated with or a beneficiary of the French single-payer social security programme (national health insurance) Exclusion Criteria: * Patient in an exclusion period determined by another protocol * Participation in another study that may affect the results of the present study (anti-cancer treatment studies are allowed) * Patient under legal or judicial protection * Contraindication to surgery or iodine injection * Pregnant or lactating women
Where this trial is running
Montpellier
- Chu Montpellier — Montpellier, France (RECRUITING)
Study contacts
- Study coordinator: Sébastien Bommart, MD, PhD
- Email: s-bommart@chu-montpellier.fr
- Phone: +33 (0)4.67.33.60.00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-small Cell Lung Cancer