Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
October 4, 2021
CompletedStudy Start
First participant enrolled
November 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2023
CompletedOctober 4, 2021
October 1, 2021
1.1 years
September 9, 2021
October 1, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Volume transfer constant (Ktrans)
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)
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)
Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.
12 months
Study Arms (1)
MRI scan
EXPERIMENTALAll participants will undergo 1 DCE-MRI scan before surgery or puncture.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Fail to understand or agree to sign informed consent
- Implanted pacemaker or cardiac defibrillator
- Contraindications to undergoing MRI
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- investigator
Study Record Dates
First Submitted
September 9, 2021
First Posted
October 4, 2021
Study Start
November 20, 2021
Primary Completion
December 15, 2022
Study Completion
March 15, 2023
Last Updated
October 4, 2021
Record last verified: 2021-10