Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization: A Single-Center Prospective Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of multiparametric chest MRI for malignancy in Lung-RADS 4 lesions
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 v
- •Able to provide written informed consent independently.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Multiparametric chest MRI with diffusion-weighted imaging (Diagnostic Test)
结局指标
主要结局
Sensitivity and specificity of multiparametric chest MRI for malignancy in Lung-RADS 4 lesions
时间窗: 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.
次要结局
- 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.)
- Interobserver agreement between the two readers(At completion of image interpretation, after both reading rounds are finished for all enrolled participants.)
- Prevalence of each MRI suspicion category(At completion of image interpretation, after both reading rounds are finished for all enrolled participants.)
- Diagnostic performance of a short (<10 minute) acquisition protocol(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(Through the enrollment period, up to 24 months from study start.)
- Interobserver agreement between the two readers(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(At completion of image interpretation, after both reading rounds are finished for all enrolled participants. Up to 48 months from study start.)