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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of contrast-enhanced MRI scans in detecting various liver lesions, both cancerous and non-cancerous. By using special contrast agents, such as gadoxetate disodium and gadobutrol (also known as Gadavist or Gadobutrol Injection), doctors aim to obtain clearer liver images to improve diagnosis. Individuals who have recently undergone an abdominal MRI and have normal kidney function might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to advancements in liver imaging techniques.

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.

What prior data suggests that contrast-enhanced MRI is safe for detecting liver lesions?

Research has shown that gadobutrol is usually well-tolerated and helps produce clear MRI images, aiding doctors in making better diagnoses. The FDA has already approved it for MRI use. However, gadolinium-based agents like gadobutrol can increase the risk of nephrogenic systemic fibrosis, a rare disease, especially in individuals with poor kidney function.

For gadoxetate disodium, research indicates it is safe for liver MRIs and works well even if kidney function is not optimal. However, limited safety data exists for children, so more research is needed. It is important to discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using contrast-enhanced MRI with gadobutrol and gadoxetate disodium for imaging liver lesions because these agents can provide more detailed images than traditional methods. Unlike standard liver imaging techniques, gadobutrol and gadoxetate disodium enhance the contrast of MRI scans, potentially allowing for earlier and more accurate detection of liver lesions. This could lead to improved diagnosis and treatment planning for patients with liver conditions. Additionally, the dynamic imaging capabilities of these agents offer real-time insights, which is a significant improvement over some existing diagnostic methods.

What evidence suggests that contrast-enhanced MRI is effective for detecting liver lesions?

Research has shown that gadobutrol, a contrast agent used in this trial, enhances MRI scans by highlighting abnormal blood vessels, making it easier to identify issues like lesions. Studies have found gadobutrol both effective and safe for improving MRI images.

Gadoxetate disodium, another contrast agent tested in this trial specifically for liver imaging, has proven effective in liver MRI scans and offers advantages over other contrast agents. It helps detect liver diseases by providing clearer images, which is crucial for diagnosing liver conditions. ^{6 7 8 9 10}

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6153968/

Gadobutrol: A Review in Contrast-Enhanced MRI and MRA Gadobutrol represents an effective and safe diagnostic GBCA for use in CE MRI and MRA to visualize pathological lesions and vascular perfusion and flow-related ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00468819

A Study of Magnetic Resonance Imaging (MRI) With ... In the participants the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, ...

3. openaccessjournals.com openaccessjournals.com/articles/overview-on-the-efficacy-and-safety-of-gadobutrol-an-mri-contrast-agent-for-the-cns-body-and-vessels.html

Overview on the efficacy and safety of gadobutrol: an MRI ... Gadobutrol improves the detection and visualization of specific features of pathological states (e.g., lesions) by showing: abnormal vascularity (called first- ...

4. dirjournal.org dirjournal.org/pdf/beb8919b-f013-4ea1-b1c8-40332e840fe1/articles/56550/Diagn%20Interv%20Radiol-12-22-En.pdf

Contrast agents used in MR imaging of the liver Gadobutrol (Gadovist®,. Schering, Germany) in 1 M concentra- tion has not been approved for use in liver parenchymal lesions. Gadobenate dimeglumine (MultiHance ...

5. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.222612

Efficacy and Safety of Half-Dose Gadopiclenol versus Full- ... Gadopiclenol at half the standard dose for contrast-enhanced body MRI had comparable efficacy with gadobutrol at the full standard dose.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2011/201277s000lbl.pdf

Gadavist (gadobutrol) injection - accessdata.fda.gov Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4395139/

Safety and Efficacy of Gadobutrol for Contrast-enhanced ... Gadobutrol is an effective and well-tolerated macrocyclic contrast agent for MRI of the CNS. Gadobutrol demonstrates greater contrast-enhancement and improved ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00623467?tab=table

Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in ... The data for contrast enhancement - gadobutrol combined was shown below. Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) ...

9. radiologysolutions.bayer.com radiologysolutions.bayer.com/products/contrast-agents/gadavist-injection

Gadavist (gadobutrol) injection Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):. To detect and visualize areas ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4089836/

Safety and Efficacy of Gadobutrol-Enhanced MRI in Patients ... This study indicates that gadobutrol at a standard dose for MRI is safe in patients aged < 2 years and provides diagnostic information for multiple pathologies.