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

October 1, 2021 updated by: Lili Cao, Qianfoshan Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI scan
All participants will undergo 1 DCE-MRI scan before surgery or puncture.
Diagnostic test: MRI scan
All participants will undergo 1 DCE-MRI scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 20, 2021

Primary Completion (Anticipated)

December 15, 2022

Study Completion (Anticipated)

March 15, 2023

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QianfoshanH Z

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Nodules

Clinical Trials on MRI scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe