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

NCT ID: NCT05067023

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-20

Study Completion Date

2023-03-15

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.

Conditions

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Pulmonary Nodules

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI scan

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

Group Type EXPERIMENTAL

MRI scan

Intervention Type DIAGNOSTIC_TEST

All participants will undergo 1 DCE-MRI scan.

Interventions

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MRI scan

All participants will undergo 1 DCE-MRI scan.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lili Cao

investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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QianfoshanH Z

Identifier Type: -

Identifier Source: org_study_id

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