Solitary Pulmonary NoduleNCT07768046
Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization
An observational study of Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Lung Neoplasms
- What is being tested?
- Multiparametric chest MRI with diffusion-weighted imaging
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Home oxygen supplementation.
- Active or treated lower respiratory tract infection within the prior 4 weeks.
- Lack of capacity to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UF Health Shands Hospital
Gainesville, Florida, 32610
Bruno Hochhegger, MD PHD, (352) 265-0291, bhochhegger@ufl.edu
Julio M. F. Zhang, MD, 6463513312, juliozhang107@gmail.com
About this study
Official title: Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization: A Single-Center Prospective Diagnostic Accuracy Study
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.
Read more
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.
Read the 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.
- Conditions
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Lung Neoplasms, Lung Cancer Screening
- Being tested
- Multiparametric chest MRI with diffusion-weighted imaging
- 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
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric chest MRI with diffusion-weighted imagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Multiparametric chest MRI with diffusion-weighted imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Optimal native T1 and T2 thresholds by ROC analysis at Youden's index, with sensitivity, specificity and 95% confidence intervals at each threshold, in participants for whom T1 and T2 mapping centered on the nodule was acquired.
Measured: 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.
Interobserver agreement between the two readers
Agreement between the two independent cardiothoracic radiologists: Cohen's kappa for the three-category suspicion classification and intraclass correlation coefficients for continuous measures (ADC, LSR, T1, T2). Interpreted as 0.01-0.20 minor, 0.21-0.40 fair, 0.41-0.60 moderate, 0.61-0.80 high, 0.81-1.00 excellent.
Measured: At completion of image interpretation, after both reading rounds are finished for all enrolled participants. Up to 48 months from study start.
Prevalence of each MRI suspicion category
Proportion of examinations classified into each of the three reader categories: (1) negative / low suspicion for malignancy, (2) indeterminate, would benefit from short-term follow-up, (3) positive / high suspicion for malignancy.
Measured: At completion of image interpretation, after both reading rounds are finished for all enrolled participants. Up to 48 months from study start.
Diagnostic performance of a short (<10 minute) acquisition protocol
Sensitivity and specificity of the abbreviated acquisition (a single diffusion sequence with restricted z-axis coverage centered on the nodule, acquisition time under 10 minutes) compared with the full protocol, to assess whether the short protocol is non-inferior.
Measured: 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.
Feasibility: prevalence of eligible patients and conversion of eligible patients to enrolled participant
Number of Lung-RADS 4 examinations screened, number meeting all eligibility criteria, and number enrolled and scanned, yielding the prevalence of eligible patients in the UF lung cancer screening population and the eligible-to-enrolled conversion rate. Stated in the source protocol as an explicit goal the sample size is intended to support.
Measured: Through the enrollment period, up to 24 months from study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary Pulmonary NoduleStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768046
- Sponsor's protocol ID
- IRB202601035
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization: A Single-Center Prospective Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT07768046
- Acronym / sponsor ID
- IRB202601035
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung-RADS 4 lesion on screening LDCT | – | Diagnostic Test: Multiparametric chest MRI with diffusion-weighted imagingAdults 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric chest MRI with diffusion-weighted imagingSingle 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. | Diagnostic test | Lung-RADS 4 lesion on screening LDCT |
Primary outcome
Sensitivity and specificity of multiparametric chest MRI for malignancy in Lung-RADS 4 lesions
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.
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.
9 secondary outcomes
Sensitivity and specificity of diffusion-weighted imaging alone
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.
Diagnostic performance of chest MRI compared with PET/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.
Apparent diffusion coefficient (ADC) threshold for malignancy
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.
Lesion-to-spinal-cord signal intensity ratio (LSR) threshold for malignancy
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.
Native T1 and T2 thresholds for malignancy
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.
Interobserver agreement between the two readers
Time frame: At completion of image interpretation, after both reading rounds are finished for all enrolled participants. Up to 48 months from study start.
Prevalence of each MRI suspicion category
Time frame: At completion of image interpretation, after both reading rounds are finished for all enrolled participants. Up to 48 months from study start.
Diagnostic performance of a short (<10 minute) acquisition protocol
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.
Feasibility: prevalence of eligible patients and conversion of eligible patients to enrolled participant
Time frame: Through the enrollment period, up to 24 months from study start.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Solitary Pulmonary Nodule
RecruitingObservational study
Biomarkers for Risk Stratification in Lung Cancer
Nodule Solitary Pulmonary, Non-small Cell Lung Cancer
RecruitingObservational study
European Real-World Registry for Use of the Ion Endoluminal System
Pulmonary Nodule, Lung Cancer
Not yet recruitingObservational study
Radiomics for Distinguishing Benign and Malignant Lung Nodules
Solitary Pulmonary Nodule, Lung Neoplasms
Recruiting
Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules
Active, not recruiting
Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Hochhegger, MD PHD ((352) 265-0291, bhochhegger@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of multiparametric chest MRI for malignancy in Lung-RADS 4 lesions (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.