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

NCT06825078 | Recruiting

• 1 other identifier: CHUBX 2023/44
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lung Cancer

Keywords

lung cancer screening; nodule; multiparametric lung MRI; low-dose chest CT; artificial intelligence

Outcome Measures

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).

  Baseline, Month 3, Month 12

Secondary Outcomes (3)

• Area under the ROC curve

  Baseline, Month 3, Month 12

• Intraclass correlation coefficient between CT and synthetic CT

  Baseline, Month 3, Month 12

• multiparametric MRI characteristics

  Baseline, Month 3, Month 12

Study Arms (1)

multiparametric MRI

EXPERIMENTAL

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.

Device: multiparametric MRI

Interventions

multiparametric MRI DEVICE

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.

multiparametric MRI

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Pessac, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Ilyes Benlala, MD

CONTACT

+335 57 65 65 42; ilyes.ben-lala@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 13, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)