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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05067023
Enrollment
50
Registered
2021-10-04
Start date
2021-11-20
Completion date
2023-03-15
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Nodules

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.

Interventions

DIAGNOSTIC_TESTMRI scan

All participants will undergo 1 DCE-MRI scan.

Sponsors

Qianfoshan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Volume transfer constant (Ktrans)12 monthsPharmacokinetic 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 monthsPharmacokinetic 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 monthsPharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026