Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions
Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI
2 other identifiers
interventional
100
1 country
1
Brief Summary
This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hepatocellular-carcinoma
Started Oct 2014
Longer than P75 for not_applicable hepatocellular-carcinoma
1 active site
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
June 3, 2014
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedStudy Start
First participant enrolled
October 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
December 22, 2025
December 1, 2025
11.6 years
June 3, 2014
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)
Summary statistics of sensitivity, specificity, true positives, true negatives, false positives, and false negatives will be provided for gadoxetate disodium and gadoxetate disodium + gadobutrol method. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be estimated along with corresponding 95% confidence intervals for the two methods. Comparison between the two methods will be made following method by Obuchowski. Other statistical analyses will be carried out as appropriate.
Up to 4 years
Study Arms (1)
Diagnostic (contrast-enhanced MRI)
EXPERIMENTALPatient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately.
Interventions
Undergo contrast-enhanced MRI
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week
- Patients with renal function (estimated glomerular filtration rate \[eGFR\] \>= 30)
- Any disease type
You may not qualify if:
- Pregnant women
- Patients with impaired renal function (eGFR \< 30)
- Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
- Patients with contraindications to the use of intravenous contrast such as allergic type reactions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janio Szklaruk, MD, PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2014
First Posted
June 5, 2014
Study Start
October 13, 2014
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
December 22, 2025
Record last verified: 2025-12