Performance of Lung MRI Combined to Synthetic CT in the Follow-up of Lung Nodules
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-74
SponsorUniversity Hospital, Bordeaux
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
multiparametric MRI
DeviceAn 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: multiparametric MRIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Positivity threshold
Positivity threshold of the combined score to obtain a specificity of at least 90%, and diagnostic performance parameters associated with this threshold (sensitivity, positive and negative predictive values).
Time frame
Baseline, Month 3, Month 12Secondary outcomes
1
Area under the ROC curve
Area under the ROC curve (AUROC) of each of the radiological parameters (nodule volume in mm3 measured on UTE images, nodule mean T1/T2 signal in msec and mean of nodule ADC in mm2/s) and of the combined multiparametric MRI score (i.e., volume and signal) in predicting nodule progression (benign vs. malignant) Area under the ROC curve (AUROC) of each of the radiological parameters (nodule volume in mm3 measured on UTE images, nodule mean T1/T2 signal in msec and mean of nodule ADC in mm2/s) and of the combined multiparametric MRI score (i.e., volume and signal) in predicting nodule progression (benign vs. malignant)
Time frame
Baseline, Month 3, Month 122
Intraclass correlation coefficient between CT and synthetic CT
Intraclass correlation coefficient between measurements performed using standard CT and synthetic CT generated from UTE MRI.
Time frame
Baseline, Month 3, Month 123
multiparametric MRI characteristics
Description of the multiparametric MRI characteristics of the different histological types of the malignant nodule.
Time frame
Baseline, Month 3, Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov