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Clinical Trials/NCT05067023
NCT05067023
Unknown
Not Applicable

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

Qianfoshan Hospital0 sites50 target enrollmentNovember 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Nodules
Sponsor
Qianfoshan Hospital
Enrollment
50
Primary Endpoint
Volume transfer constant (Ktrans)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2021
End Date
March 15, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Qianfoshan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lili Cao

investigator

Qianfoshan Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Volume transfer constant (Ktrans)

Time Frame: 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)

Time Frame: 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)

Time Frame: 12 months

Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

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