Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging

Study Overview
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Brief Summary
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Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of dynamic contrast-enhanced MR imaging (DCE-MRI) to discriminate of malignant from benign lesions.

Detailed Description
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Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of DCE-MRI to discriminate of malignant from benign lesions.In this study, the investigators are going to validate the efficacy of the DCE-MRI for diagnosing early lung cancer by comparing results of the pre-surgery MRI imaging with the post-surgery pathology.

Official Title
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Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging

Conditions
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Pulmonary Nodules

Intervention / Treatment
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* Diagnostic Test: MRI scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ground-glass pulmonary nodules found by CT scan Plan to accept surgery or puncture due to the pulmonary nodules Absence of treatment such as chemotherapy or radiotherapy and biopsy Adequate renal function to tolerate intravenous gadolinium Agree to sign informed consent Able to lie still during DCE-MRI Exclusion Criteria: Fail to understand or agree to sign informed consent Implanted pacemaker or cardiac defibrillator Contraindications to undergoing MRI Uncontrolled intercurrent illness Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI scan<br>All participants will undergo 1 DCE-MRI scan before surgery or puncture. | Diagnostic Test: MRI scan<br>* All participants will undergo 1 DCE-MRI scan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume transfer constant (Ktrans) | Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI. | 12 months | 
| the fractional volume of extravascular extracellular space of the target tissue (ve) | Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI. | 12 months | 
| the rate constant (kep) | Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI. | 12 months |