Contrast-enhanced MRI for Liver Lesions

Overseen By Vikas Kundra, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Impaired renal function, Implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is contrast-enhanced MRI using gadolinium-based agents like Gadobutrol and Gadoxetate Disodium safe for humans?

Studies show that gadolinium-based agents like Gadobutrol and Gadoxetate Disodium are generally safe for use in MRI scans. In a study with 8194 patients, only 1.7% reported mild side effects like shortness of breath and nausea, and no deaths occurred. Additionally, over 29 million applications of Gadobutrol have shown no increased risk of side effects, even in children and those with liver or kidney issues. ^{1 2 3 4 5}

How does contrast-enhanced MRI for liver lesions differ from other treatments?

Contrast-enhanced MRI for liver lesions using gadoxetate disodium is unique because it is a liver-specific contrast agent that enhances imaging by being partially taken up by liver cells, providing clearer images of liver lesions compared to other contrast agents like gadobutrol, which are not liver-specific. ^{3 6 7 8 9}

What data supports the effectiveness of the drug Gadobutrol for liver lesions?

Research shows that Gadobutrol, a contrast agent used in MRI scans, is effective in enhancing images of liver lesions, helping doctors distinguish between benign (non-cancerous) and malignant (cancerous) lesions. It is formulated at a higher concentration than some other agents, which improves image clarity and diagnostic accuracy. ^{7 8 9 10 11}

Who Is on the Research Team?

Janio Szklaruk, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My condition does not limit my eligibility based on disease type.

Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week

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

Exclusion Criteria

My kidney function is low (eGFR < 30).

I am allergic to or cannot have IV contrast.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

Participants receive gadoxetate disodium intravenously and undergo MRI, followed by gadobutrol administration and further MRI imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for clinical stability and follow-up imaging

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Gadobutrol
• Gadoxetate Disodium

Trial Overview 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.

How Is the Trial Designed?

Group I: Diagnostic (contrast-enhanced MRI) Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Gadobutrol, a second-generation gadolinium-based contrast agent, is effective for enhancing MRI images across various medical fields, allowing for better visualization of pathological lesions and improved diagnostic capabilities.

It is generally well tolerated in a wide range of patients, including those with renal or hepatic impairments, and has a lower risk of causing nephrogenic systemic fibrosis compared to older linear GBCAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadobutrol: a review of its use for contrast-enhanced magnetic resonance imaging in adults and children. Scott, LJ.[2021]

Magnetic resonance imaging (MRI) is highly effective for diagnosing liver and bile duct issues in children, with noncontrast MRI showing good results due to the visibility of bile.

Using the hepatocyte-specific contrast agent gadoxetate disodium (Eovist) enhances MRI by providing better characterization of liver lesions through its partial excretion, although there are specific applications and limitations to consider in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Eovist in Pediatric Patients: Pearls and Pitfalls. Shet, NS., Flynn, JF., Maloney, E., et al.[2021]

In a study involving 8194 patients across multiple countries, gadoxetate disodium was found to have a low adverse event rate of 1.7%, indicating it is generally safe for routine use in liver MRI.

The most common adverse events were mild, such as dyspnea and nausea, and importantly, no serious adverse events were related to the drug in the pediatric population, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients. Endrikat, J., Kim, SY., Sakaguchi, T., et al.[2018]

Gadobutrol, a gadolinium-based contrast agent, demonstrated a high safety margin in preclinical studies, with no adverse effects observed at doses 10 to 12 times higher than the standard diagnostic dose used in humans (0.1 mmol/kg).

The compound was well tolerated in animal studies, showing no teratogenic effects and no indications of genotoxicity or immunotoxicity, making it a safe option for use in magnetic resonance imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicological safety evaluation of gadobutrol. Wack, C., Steger-Hartmann, T., Mylecraine, L., et al.[2019]

Gadobutrol, a macrocyclic contrast agent, has an excellent safety profile, with only 4.0% of patients experiencing adverse events in clinical trials, comparable to other contrast agents.

The safety of gadobutrol was confirmed across various patient populations, including children and those with renal or hepatic impairments, with serious adverse reactions being very rare in over 5.7 million administrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance. Voth, M., Rosenberg, M., Breuer, J.[2014]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Gadobutrol: a review of its use for contrast-enhanced magnetic resonance imaging in adults and children. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Liver perfusion in dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI): comparison of enhancement in Gd-BT-DO3A and Gd-EOB-DTPA in normal liver parenchyma. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Contrast-enhanced MR angiography of the arterial and portovenous system of the liver with varying concentrations of contrast medium]. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a multicenter, double-blind, interindividual, randomized clinical phase-III trial. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Use of Eovist in Pediatric Patients: Pearls and Pitfalls. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Toxicological safety evaluation of gadobutrol. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Gadobutrol in India-A Comprehensive Review of Safety and Efficacy. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of gadobutrol-enhanced MRI in patients aged under 2 years-a single-center, observational study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Gadolinium retention in rat abdominal organs after administration of gadoxetic acid disodium compared to gadodiamide and gadobutrol. [2021]