Hepatocellular Carcinoma Clinical Trial
Official title:
Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI
Verified date | April 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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