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Contrast-enhanced MRI for Liver Lesions

N/A

Waitlist Available

Led By Vikas Kundra

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with renal function (estimated glomerular filtration rate [eGFR] >= 30)

Be older than 18 years old

Must not have

Patients with impaired renal function (eGFR < 30)

Patients with contraindications to the use of intravenous contrast such as allergic type reactions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial uses MRI to look for non-cancerous and cancerous liver lesions, with contrast agents to help make the MRI images clearer.

Who is the study for?

This trial is for people who've had an abdominal MRI within the last 3 months and have a kidney function score (eGFR) of 30 or above. It's open to any disease type, but not for those with poor kidney function, allergies to IV contrast, pregnant women, or individuals with certain metal implants.

What is being tested?

The study is testing how well contrast-enhanced MRI can spot liver lesions that are either benign (not cancer) or malignant (cancer). It uses two types of contrast agents - gadobutrol and gadoxetate disodium - to improve image clarity and assist in diagnosis.

What are the potential side effects?

Potential side effects from the contrast agents include allergic reactions like itching or rash, headache, nausea, dizziness, changes in taste sensation, feeling hot or cold. Kidney issues could also occur especially if there's pre-existing kidney disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is at a safe level for the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is low (eGFR < 30).

Select...

I am allergic to or cannot have IV contrast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (contrast-enhanced MRI)Experimental Treatment3 Interventions

Patient 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contrast-enhanced Magnetic Resonance Imaging

2005

Completed Phase 1

~320

Gadobutrol

FDA approved

Gadolinium

FDA approved