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

Not Applicable

• Conditions: Pulmonary Nodules
• Interventions: Diagnostic Test: MRI scan

• Registration Number: NCT05067023
• Lead Sponsor: Qianfoshan Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-09-09
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Study First Posted: 2021-10-04
• Last Update Posted: 2021-10-04
• Study Start: 2021-11-20
• Primary Completion: 2022-12-15
• Study Completion: 2023-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI scan	MRI scan	All participants will undergo 1 DCE-MRI scan before surgery or puncture.

Primary Outcome Measures

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