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Lung Neoplasms / Multiple Pulmonary Nodules / Solitary Pulmonary Nodule · Observational Study
ClinicalTrials.gov · August 19, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective observational pilot study registered but not yet recruiting to evaluate non-contrast multiparametric MRI with diffusion-weighted imaging for distinguishing malignant from benign Lung-RADS 4 nodules. No efficacy data are yet available; the study is designed to assess feasibility, protocol optimization, and preliminary diagnostic performance estimates in a small population.
Observational. Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Lung Neoplasms, Lung Cancer Screening; age from 50 Years; to 80 Years. Intervention: Lung-RADS 4 lesion on screening LDCT. Compared with: Final diagnosis: histopathology or microbiology when tissue obtained; otherwise ≥24 months clinical and imaging follow-up. Secondary comparisons planned with PET/CT (in participants who receive it as part of standard care).. n = 30. 1 site: United States.
This is a prospective observational pilot study registered but not yet recruiting to evaluate non-contrast multiparametric MRI with diffusion-weighted imaging for distinguishing malignant from benign Lung-RADS 4 nodules. No efficacy data are yet available; the study is designed to assess feasibility, protocol optimization, and preliminary diagnostic performance estimates in a small population.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study does not yet provide clinical evidence. When results are available, preliminary diagnostic performance of non-contrast MRI-DWI for Lung-RADS 4 lesion triage could inform future imaging protocols, but sample size and pilot design limit generalizability and any practice recommendations must await confirmatory study.
This is a prospective observational pilot study not yet recruiting, with no results posted; it aims to establish feasibility and generate preliminary diagnostic performance estimates for a novel MRI protocol in lung lesion characterization.
As stated by the source record.
Quoted from the source exactly as published.
This study does not yet provide clinical evidence. When results are available, preliminary diagnostic performance of non-contrast MRI-DWI for Lung-RADS 4 lesion triage could inform future imaging protocols, but sample size and pilot design limit generalizability and any practice recommendations must await confirmatory study.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07768046). This is a study registration, not published results. Lead sponsor: University of Florida. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Lung Neoplasms, Lung Cancer Screening. Interventions: DIAGNOSTIC_TEST: Multiparametric chest MRI with diffusion-weighted imaging. Primary outcome measures: Sensitivity and specificity of multiparametric chest MRI for malignancy in Lung-RADS 4 lesions , From the research MRI to establishment of the final diagnosis: histopathology or microbiology when tissue is obtained, otherwise at least 24 months of clinical and imaging follow-up per participant.. Brief summary: 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.
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