Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorUniversity of Florida
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 50 to 80 years, inclusive.
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).
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.
Able to provide written informed consent independently.
Disqualifiers
Part-solid or cystic nodule with a solid component measuring less than 8 mm.
Endobronchial nodule.
MRI-incompatible or potentially MRI-incompatible implanted device.
Claustrophobia that would prevent the participant from tolerating the MRI examination.
Trial population
Adults aged 50 to 80 years enrolled in the University of Florida lung cancer screening program who meet 2021 USPSTF screening eligibility (at least a 20 pack-year smoking history, currently smoking or quit within the past 15 years) and whose standard-of-care screening low-dose chest CT was assigned Lung-RADS category 4 (4A, 4B, or 4X). Participants are identified consecutively from institutional lung cancer screening CT reports and approached through a treating clinician who is a listed investigator, or through the UF Consent2Share registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Multiparametric chest MRI with diffusion-weighted imaging
Diagnostic testSingle non-contrast chest MRI on a 3.0 Tesla scanner (GE Healthcare or Siemens Healthineers) with a vendor-specific surface coil. Sequences: axial breath-hold 2D in- and opposed-phase gradient echo T1-weighted imaging; axial breath-hold and/or respiratory-triggered multi-shot fat-suppressed EPI DWI with two b values; reduced-FOV DWI centered on the nodule; axial respiratory-triggered T2-weighted imaging with fat suppression or Dixon. Optional UTE and T1/T2 mapping if time allows. No intravenous or other contrast material is administered.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Lung-RADS 4 lesion on screening LDCT1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity and specificity of multiparametric chest MRI for malignancy in Lung-RADS 4 lesions
Sensitivity and specificity, each with a 95% confidence interval, of the reader classification of multiparametric chest MRI (full protocol) for malignant versus benign lesion, against the final clinical diagnosis as the reference standard. Reported both excluding and including examinations classified as indeterminate, to determine whether indeterminate examinations are better grouped with low or with high suspicion.
Time frame
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.Secondary outcomes
1
Sensitivity and specificity of diffusion-weighted imaging alone
Sensitivity and specificity with 95% confidence intervals of the reader classification based on DWI alone read in conjunction with the companion low-dose CT (round 1), against the final clinical diagnosis, for comparison with the full-protocol estimates (Aim 2).
Time frame
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.2
Diagnostic performance of chest MRI compared with PET/CT
Sensitivity and specificity of chest MRI and of standard-of-care PET/CT compared pairwise by McNemar's test, in the subset of participants whose PET/CT was performed within a 3-week interval (Aim 3). PET/CT is standard of care and is not scheduled by the study.
Time frame
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.3
Apparent diffusion coefficient (ADC) threshold for malignancy
Optimal ADC threshold identified by ROC analysis at Youden's index, with the sensitivity, specificity and 95% confidence intervals at that threshold. ADC is measured from a circular or elliptical region of interest placed over the lowest-signal component of the nodule, avoiding artifact, with correlation to the low-dose CT.
Time frame
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.4
Lesion-to-spinal-cord signal intensity ratio (LSR) threshold for malignancy
Optimal LSR threshold by ROC analysis at Youden's index with sensitivity, specificity and 95% confidence intervals. LSR is calculated from the signal intensity of the nodule and of the spinal cord measured at the same level.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov
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