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Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization

Not Yet RecruitingN/A

Sponsor: University of Florida

Conditions: Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Lung Neoplasms, Lung Cancer Screening

Interventions: Multiparametric chest MRI with diffusion-weighted imaging

Countries: United States

This study evaluates whether multiparametric chest magnetic resonance imaging (MRI) with diffusion-weighted imaging (DWI), performed without any contrast material, can distinguish malignant from benign lung lesions that were assigned Lung-RADS category 4 on a standard-of-care lung cancer screening low-dose CT. Participants who have a Lung-RADS 4 lesion on screening CT undergo one non-contrast research MRI of the chest at 3.0 Tesla. The MRI is added to standard care; no standard-of-care imaging, biopsy, or treatment is withheld or replaced, and the research MRI is not used for clinical decision making. Participants then continue routine clinical management, and the final nature of the lesion is established from pathology or microbiology when tissue is obtained, or otherwise from at least 24 months of clinical and imaging follow-up. The primary measure is the sensitivity and specificity of multiparametric MRI against that final diagnosis. Secondary measures include whether DWI alone performs as well as the full MRI protocol, how MRI compares with PET/CT in participants who had PET/CT as part of their care, and quantitative MRI thresholds (apparent diffusion coefficient, lesion-to-spinal-cord signal intensity ratio, native T1 and T2). This is an exploratory pilot and feasibility study. No formal power calculation was performed; the sample size is intended to support feasibility assessment, protocol optimization, and preliminary estimates of diagnostic performance.

Eligibility overview

Sex: ALL

Age: 50 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Age 50 to 80 years, inclusive.
2. At least a 20 pack-year cigarette smoking history, and currently smoking or quit within the past 15 years (2021 USPSTF lung cancer screening eligibility).
3. Underwent a standard-of-care lung cancer screening low-dose chest CT (LDCT) at the University of Florida that was assigned Lung-RADS category 4 (4A, 4B, or 4X) per ACR Lung-RADS v2022.
4. Able to provide written informed consent independently.

Exclusion Criteria:

1. Part-solid or cystic nodule with a solid component measuring less than 8 mm.
2. Endobronchial nodule.
3. MRI-incompatible or potentially MRI-incompatible implanted device.
4. Claustrophobia that would prevent the participant from tolerating the MRI examination.
5. Metallic device in the chest wall or spine that may interfere with adequate image acquisition in the field of view (assessed case by case).
6. History of prior lung resection for a benign condition that may create susceptibility artifact in the field of view.
7. Home oxygen supplementation.
8. Active or treated lower respiratory tract infection within the prior 4 weeks.
9. Lack of capacity to consent.

Locations (1)

Gainesville, Florida, United States