Clinical trial · Interventional
Performance of Lung MRI Combined to Synthetic CT in the Follow-up of Lung Nodules
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| multiparametric MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- multiparametric MRI
- description
- 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.
- interventionNames
- Device: multiparametric MRI
Primary outcomes (1)
- measure
- Positivity threshold
- timeFrame
- Baseline, Month 3, Month 12
- description
- 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).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (0)
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