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

NCT07768046 | Not Yet Recruiting

• 1 other identifier: IRB202601035
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules; Lung Neoplasms; Lung Cancer Screening

Keywords

Lung-RADS 4; diffusion-weighted imaging; apparent diffusion coefficient; multiparametric MRI; lung cancer screening; low-dose CT; pulmonary nodule; diagnostic accuracy; non-contrast MRI

Outcome Measures

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.

  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 (9)

• Sensitivity and specificity of diffusion-weighted imaging alone

  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.

• Diagnostic performance of chest MRI compared with PET/CT

  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.

• Apparent diffusion coefficient (ADC) threshold for malignancy

  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.

• Lesion-to-spinal-cord signal intensity ratio (LSR) threshold for malignancy

  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.

• Native T1 and T2 thresholds for malignancy

  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.

Study Arms (1)

Lung-RADS 4 lesion on screening LDCT

Adults aged 50-80 who meet 2021 USPSTF lung cancer screening criteria and have a Lung-RADS category 4 (4A, 4B, or 4X) lesion on a standard-of-care lung cancer screening low-dose chest CT. Each participant undergoes one non-contrast multiparametric chest MRI at 3.0 T for research purposes, in addition to standard of 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 continue routine clinical management; the final nature of the lesion is established from histopathology or microbiology when tissue is obtained, or otherwise from at least 24 months of clinical and imaging follow-up.

Diagnostic Test: Multiparametric chest MRI with diffusion-weighted imaging

Interventions

Multiparametric chest MRI with diffusion-weighted imaging DIAGNOSTIC_TEST

Single 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.

Lung-RADS 4 lesion on screening LDCT

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Shands Hospital

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules; Lung Neoplasms

Interventions

Diffusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Bruno Hochhegger, MD PHD

CONTACT

(352) 265-0291; bhochhegger@ufl.edu

Julio M. F. Zhang, MD

CONTACT

6363513312; juliozhang107@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

US (1)