Evaluating lung MRI and synthetic CT for lung nodule follow-up
Performance of Lung MRI Combined to Synthetic CT in the Follow-up of Lung Nodules
This study is testing if a new way of using lung MRI with synthetic CT can safely monitor lung nodules in high-risk people, like heavy smokers, without the need for invasive tests or repeated radiation exposure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 55 Years to 74 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pessac) |
| Trial ID | NCT06825078 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of multiparametric lung MRI combined with synthetic CT in monitoring lung nodules in high-risk individuals, particularly heavy smokers or those exposed to carcinogens. The approach seeks to reduce the risks associated with invasive diagnostic methods and the exposure to ionizing radiation from repeated chest CT scans. By utilizing advanced MRI techniques, the study hopes to provide a non-invasive alternative for lung cancer diagnosis and follow-up. The study is a prospective pilot conducted at a single center, following recommendations from health authorities to explore new lung cancer screening methods.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 to 74 with a significant smoking history and at least one lung solid nodule of 5mm or larger.
Not a fit: Patients with a history of lung cancer, severe comorbidities, or contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more accurate method for monitoring lung nodules, potentially reducing unnecessary invasive procedures.
How similar studies have performed: Previous studies have indicated that MRI can be a viable alternative to CT for lung nodule assessment, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject aged between 55 and 74 years * High risk of developing lung cancer: by a combination of exposure to lung carcinogens and smoking (exposure to tobacco at the rate of 30 packs/year or cessation \< 15 years) * Presence of at least one lung solid nodule ≥ 5mm on the initial scan. * Subject able and willing to complete all scheduled visits and assessments. * Subject with health insurance. * Signed informed consent. Exclusion Criteria: * Subject with signs of lung cancer * Subject with history of lung cancer * Presence of severe life-threatening comorbidities at 6 months (recent CVA, recent discovery of advanced stage cancer) * Subject who had already undergone a chest scan less than a year previously * No exposure to occupational lung carcinogens according to the predefined criteria. * No exposure to tobacco or insufficient exposure to tobacco or cessation \> 15 years. * Contra-indication to MRI (Pace maker, implants, claustrophobia…) * Pregnant or breastfeeding woman * Poor understanding of French * Subject under legal protection
Where this trial is running
Pessac
- CHU Bordeaux — Pessac, France (Recruiting)
Study contacts
- Study coordinator: Ilyes Benlala, MD
- Email: ilyes.ben-lala@chu-bordeaux.fr
- Phone: +335 57 65 65 42
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.