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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02156739
Other study ID # 2012-1157
Secondary ID NCI-2014-0233320
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 13, 2014
Est. completion date June 1, 2025

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

PRIMARY OBJECTIVES: I. To compare the specificity of contrast enhanced MRI using a liver specific agent Eovist (gadoxetate disodium) versus the combined use of Eovist and an intravascular-extracellular agent Gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging. OUTLINE: Patients receive gadoxetate disodium intravenously (IV) over 1 minute and undergo MRI. Patients then receive gadobutrol IV over 1 minute at the 20 minute mark during MRI.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Contrast-enhanced Magnetic Resonance Imaging
Undergo contrast-enhanced MRI
Drug:
Gadobutrol
Given IV
Gadoxetate Disodium
Given IV

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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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