Performance of Lung MRI Combined to Synthetic CT in the Follow-up of Lung Nodules

Recruiting · NCT06825078 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Bordeaux

View the official record on ClinicalTrials.gov →

Lung Cancer

Interventions studied

multiparametric MRI

What this trial is about

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 take part

Age range

55 Years to 74 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 it is running

1 location listed.

CHU Bordeaux - Pessac, France

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →