Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization | NCT07768046 | Trialant

Not yet recruitingObservationalUpdated Aug 19, 2026

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

Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization: A Single-Center Prospective Diagnostic Accuracy Study

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07768046
Lead Sponsor: University of FloridaOTHER
Overall Status: Not yet recruiting
Study Type: Observational
Enrollment: 30Estimated
Last Update Posted: Aug 19, 2026Actual
Start Date: Jan 2027Estimated
Primary Completion Date: Jan 2031Estimated
Completion Date: Jan 2032Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization: A Single-Center Prospective Diagnostic Accuracy Study
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.

Conditions

The medical conditions and diseases this study investigates.

Solitary Pulmonary Nodule
Multiple Pulmonary Nodules
Lung Neoplasms

Interventions

The treatments and procedures being evaluated in this study.

Multiparametric chest MRI with diffusion-weighted imaging

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Metallic device in the chest wall or spine that may interfere with adequate image acquisition in the field of view (assessed case by case).

History of prior lung resection for a benign condition that may create susceptibility artifact in the field of view.

Home oxygen supplementation.

Active or treated lower respiratory tract infection within the prior 4 weeks.

Lack of capacity to consent.

Design

How the study is designed and how its participant groups are organized.

Observational Model: Cohort
Time Perspective: Prospective

Contacts

The people to reach with questions about this study or how to join it.

Bruno Hochhegger, MD PHDContact

bhochhegger@ufl.edu(352) 265-0291

Locations

Where the study is run and whether each site is currently recruiting.

UF Health Shands Hospital

Gainesville, Florida 32610, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: University of FloridaOTHER

Similar Studies

Other registered studies that closely resemble this one.

Detailed Description

OBJECTIVES

Aim 1. Determine the sensitivity and specificity of multiparametric chest MRI with DWI in differentiating malignant from benign Lung-RADS 4 lesions.

Aim 2. Determine whether DWI alone is as effective as the full chest protocol in malignancy classification of Lung-RADS 4 lesions.

Aim 3. Compare the diagnostic performance of chest MRI to PET/CT in the characterization of Lung-RADS 4 lesions.

DESIGN

Single-center prospective observational cohort study of diagnostic accuracy at the University of Florida. Participants identified from the institutional lung cancer screening program with a Lung-RADS 4 (4A, 4B, 4X) finding on standard-of-care low-dose CT undergo one non-contrast research chest MRI. There is no randomization and no comparator group; the comparator is the reference standard (final clinical diagnosis) and, for Aim 3, the participant's standard-of-care PET/CT where performed.

INDEX TEST

All examinations are performed on a 3.0 Tesla scanner (GE Healthcare or Siemens Healthineers) with a vendor-specific surface coil; an interlocking neck coil may be added to the torso coil for apical lesions. No intravenous or other contrast material is administered. Sequences comprise axial breath-hold 2D in- and opposed-phase gradient echo T1-weighted imaging; axial breath-hold and/or respiratory-triggered DWI using multi-shot fat-suppressed echo-planar imaging with two b values; DWI sequences with restricted z-axis coverage centered on the nodule (EPI-DWI, FOCUS/ZOOMit-EPI, MUSE/RESOLVE); and axial respiratory-triggered T2-weighted imaging with fat suppression or Dixon. Ultra-short echo time imaging and T1/T2 mapping centered on the nodule may be added if time allows. Pulse-sequence parameters are optimized to the vendor platform during a pre-clinical optimization phase and after the first participants are scanned.

IMAGE ANALYSIS

Anonymized MRI examinations are read independently by two cardiothoracic radiologists with more than 5 years of MRI experience. Readers have the companion low-dose CT but are blinded to clinical data and to any additional imaging. Reading proceeds in two rounds: DWI alone in conjunction with the LDCT (Aim 2), then the full set of sequences (Aim 1). Each examination is classified as (1) negative / low suspicion for malignancy, (2) indeterminate, would benefit from short-term follow-up, or (3) positive / high suspicion for malignancy. Quantitative measures are the apparent diffusion coefficient from a circular or elliptical ROI over the lowest-signal component of the nodule, and the nodule-to-spinal-cord signal intensity ratio measured at the same level.

REFERENCE STANDARD

The final etiology of the lesion is determined by histopathological and/or microbiological data when available, or otherwise by imaging and clinical follow-up for at least 24 months. A lesion that disappears or decreases in size on follow-up is deemed benign; a lesion that remains stable for at least 24 months is deemed benign.

STATISTICAL ANALYSIS

Sensitivity and specificity of chest MRI and of DW-MRI alone are reported with 95% confidence intervals, computed both excluding and including indeterminate examinations. For participants whose standard-of-care PET/CT was performed within a 3-week interval, sensitivity and specificity of the two modalities are compared pairwise by McNemar's test. Thresholds for ADC, lesion-to-spinal-cord ratio, native T1 and T2 are explored by ROC analysis at Youden's index. Interobserver agreement is assessed by kappa for categorical variables and intraclass correlation for continuous variables. Analyses are performed in R version 4.4.1 or higher at a significance level of 0.05. No interim analysis is planned.