Blood Tests + MRI for Liver Cancer

(HepQuant Trial)

Recruiting at 1 trial location

Overseen By Rikin Gandhi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must not be taking: Non-selective beta blockers, ACE inhibitors

Disqualifiers: Pregnancy, Claustrophobia, MRI contraindications, others

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if special MRI scans and blood tests can track liver function in liver cancer patients undergoing radiation therapy. It focuses on patients with liver cancer types such as hepatocellular carcinoma, cholangiocarcinoma, or liver metastases. The study will test two groups: one receiving both the MRI and a blood test called HepQuant DuO (a specialized blood test for liver function), and the other receiving only the MRI. Individuals who have previously undergone various cancer treatments, including radiation, may qualify if they can undergo MRI scans. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance liver cancer treatment monitoring.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are participating in the HepQuant subset of the trial, you may need to delay taking certain medications like non-selective beta blockers or ACE inhibitors on the morning of the test.

What prior data suggests that these methods are safe for liver cancer patients?

Research has shown that the HepQuant DuO test measures liver function by assessing how effectively the liver processes cholate, a natural substance. Patients have used this test to evaluate liver function, and no major safety issues have been reported. The test uses labeled cholates, administered either through an IV or orally.

These components are generally well-tolerated because they resemble substances the body naturally handles. Studies have not identified any significant adverse effects directly linked to this test. This suggests that HepQuant DuO is safe for assessing liver health in individuals receiving treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines blood tests and MRI scans to potentially improve the detection and diagnosis of liver cancer. Unlike standard diagnostic methods that often rely on imaging alone, this approach uses the HepQuant DuO test, which measures liver function with more precision and less invasiveness. By integrating these innovative blood tests with advanced MRI technology, the trial aims to offer a more comprehensive view of liver health, potentially leading to earlier and more accurate cancer detection. This could be a game-changer in diagnosing liver cancer, providing a quicker and more detailed assessment compared to existing methods.

What evidence suggests that this trial's methods could be effective for liver cancer?

Research has shown that the HepQuant DuO test, which participants in this trial may receive, effectively assesses liver function by measuring how the liver processes cholate, a natural substance. This test has proven useful in detecting changes in liver function in individuals with liver issues, making it a valuable tool for managing long-term liver diseases. Studies suggest it links liver function with various patient traits and disease types. It is also considered cost-effective for managing liver conditions. While it does not directly treat liver cancer, its ability to monitor liver function is important for understanding how treatments like radiation therapy affect the liver. ^{1 2 5 6 7}

Who Is on the Research Team?

Rafi Kabarriti, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases who are undergoing photon radiation therapy. It's a pilot study to see if MRI scans and blood tests can monitor liver function before and after treatment.

Inclusion Criteria

Concurrent enrollment on other prospective registry or treatment intention trials is allowed

Patient provides study-specific informed consent prior to study entry

My cancer has spread, and it can be targeted for treatment.

Exclusion Criteria

Pregnant or breast-feeding females

Subjects with history of claustrophobia impacting ability to perform MRI during the study

Subjects who fulfill any of the contraindications for MRI; examples include any ferromagnetic material, any metallic shrapnel or fragments or implanted electronic devices contained within the body or metal-containing tattoos

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive stereotactic body radiotherapy (SBRT) for liver cancer

Approximately 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in liver function and volume

12 months

What Are the Treatments Tested in This Trial?

Interventions

• HepQuant DuO

Trial Overview The study is testing the use of quantitative multiparametric MRI scans alongside HepQuant DuO blood tests as methods to measure and monitor liver function in patients receiving radiation therapy for various types of liver cancer.

How Is the Trial Designed?

Group I: Multiparametric MRI scans and HepQuant Duo Test Experimental Treatment 2 Interventions

Group II: Multiparametric MRI scans only Active Control 1 Intervention

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Perspectum

Industry Sponsor

Trials

36

Recruited

13,600+

HepQuant, LLC

Industry Sponsor

Trials

7

Recruited

420+

Published Research Related to This Trial

An abbreviated liver MRI protocol using HBP gadoxetate disodium-enhanced T1-weighted and DWI sequences provides diagnostic results comparable to a standard MRI protocol for assessing colorectal liver metastases in 113 patients, indicating it can effectively evaluate disease presence and treatment response.

The abbreviated protocol significantly reduces imaging time while maintaining high agreement in assessing segmental involvement and treatment response, suggesting it is a practical alternative for post-treatment follow-up without compromising diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Performance of Abbreviated Liver MRI for the Follow-Up of Patients With Colorectal Liver Metastases. Torkzad, MR., Riddell, AM., Chau, I., et al.[2021]

Non-contrast abbreviated magnetic resonance imaging (aMRI) is a cost-effective method for hepatocellular carcinoma (HCC) surveillance in cirrhotic patients, showing incremental cost-effectiveness ratios of $3,667 per quality-adjusted life year (QALY) in Thailand and $37,062 per QALY in the United States.

aMRI outperforms the combination of ultrasonography and alpha-fetoprotein (AFP) testing in cost-effectiveness, particularly in populations with higher HCC incidence, making it a valuable tool for early detection in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Utility Analysis of Non-Contrast Abbreviated Magnetic Resonance Imaging for Hepatocellular Carcinoma Surveillance in Cirrhosis. Decharatanachart, P., Pan-Ngum, W., Peeraphatdit, T., et al.[2023]

Gadoxetic acid disodium (Gd-EOB-DTPA) was found to be well tolerated, indicating a good safety profile for patients undergoing MRI for liver lesions.

The use of Gd-EOB-DTPA-enhanced MRI significantly improved the accurate characterization of liver lesions compared to unenhanced MRI and spiral CT, with correct characterization rates of 96% for combined MRI versus 84% and 85% for the other methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved characterization of focal liver lesions with liver-specific gadoxetic acid disodium-enhanced magnetic resonance imaging: a multicenter phase 3 clinical trial. Raman, SS., Leary, C., Bluemke, DA., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06899152

HepQuant: Study to Assess the Role of Blood-based ... HepQuant DuO may offer a unique capability to assesses liver functional impairment across the spectrum of injury and fibrosis in patients undergoing radiation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11584119/

Cost-effectiveness of an oral cholate challenge test for the ... Clinical decisions based on DSI from DuO are cost-effective in the management of patients with chronic liver disease suspected of having large esophageal ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/liv.70036

Rencofilstat Treatment Improves Liver Function in MASH ... The HepQuant DuO test detected a significant improvement in hepatic function in subjects treated with 225 mg/d of rencofilstat. Abbreviations ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/587376

HepQuant: Study to Assess the Role of Blood-based ... HepQuant DuO is a quantitative liver function test. It assesses cholate uptake, a liver specific function. Cholate is a naturally occurring ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11348877/

Liver Function and Portal-Systemic Shunting Quantified by the ... Conclusions: DSI from HepQuant DuO links liver function and physiology to the risk of LEVs across a wide spectrum of patient characteristics, disease ...

6. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3265?af=R

Hepatic Dysfunction Quantified by HepQuant DuO ... HepQuant tests quantify liver function from clearance of deuterium- and 13C-labeled cholates administered either intravenously and orally ...

7. hepquant.com hepquant.com/products-services/hepquant-duo/

HepQuant DuO The HepQuant DuO Test is a quantitative test of liver health. It assesses cholate uptake, a liver specific function.