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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 74
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Bordeaux
RECRUITING
Pessac
Contact Information
Primary
Ilyes Benlala, MD
ilyes.ben-lala@chu-bordeaux.fr
+335 57 65 65 42
Time Frame
Start Date: 2025-02-12
Estimated Completion Date: 2027-02
Participants
Target number of participants: 50
Treatments
Experimental: multiparametric MRI
An MRI scan will be performed within 2 weeks of the discovery of a solid lung nodule ≥ 5mm on the screening scan.~When a follow-up scan is indicated, an MRI will be repeated on the same day as the follow-up scan.~The MRI sequences that will be performed are: SpiraleVibe UTE, T1map, T2 map and Diffusion.~A synthetic scanner image will be generated from the UTE morphological MRI image using a generative artificial intelligence (GAN) model.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov

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