Performance of Lung MRI Combined to Synthetic CT in the Follow-up of Lung Nodules (NCT06825078) | Clinical Trial Compass
RecruitingNot Applicable
Performance of Lung MRI Combined to Synthetic CT in the Follow-up of Lung Nodules
France50 participantsStarted 2025-02-12
Plain-language summary
Lung cancer screening trials using low-dose chest CT scans have shown a significant reduction of cancer related mortality in subjects at high risk of lung cancer. However, high rate of false positives and overdiagnosis have led to invasive methods, which are not without risks. Evaluation of lung nodules using lung MRI with ultra short echo time sequences (UTE) has been found comparable to chest CT scans. Moreover, MRI has the advantage of multiparametric characterization of lesions using different tissue contrasts. Following the recommendation of the French National Authority for Health (HAS) to evaluate new methods of lung cancer screening, this prospective single center pilot study is designed to evaluate the performance of multiparametric lung MRI combined to synthetic CT in the diagnosis of lung cancer in heavily smokers or ex-smokers professionally exposed to carcinogens
Who can participate
Age range
55 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.