Blood Tests + MRI for Liver Cancer

(HepQuant Trial)

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

Trial Summary

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.

Is the MRI procedure for liver cancer screening safe?

The MRI procedure using gadoxetic acid disodium for liver imaging has been evaluated for safety in a clinical trial, indicating it is generally safe for humans. ^{1 2 3 4 5}

How does the Blood Tests + MRI treatment for liver cancer differ from other treatments?

This treatment is unique because it combines blood tests with advanced MRI techniques, potentially using specialized contrast agents like manganese dipyridoxal diphosphate (MnD-PDP), to improve the detection of liver cancer. Unlike standard imaging methods, this approach may offer higher sensitivity in identifying liver lesions, which could lead to earlier and more accurate diagnosis. ^{4 6 7 8 9}

What is the purpose of this trial?

This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary histology, that are undergoing photon radiation either in the de-novo or re-irradiation setting. The goal of this study is to prospectively evaluate the feasibility of using quantitative multiparametric MRI to monitor liver function at baseline and following liver radiation therapy.

Research Team

Rafi Kabarriti, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Clinical Performance of Abbreviated Liver MRI for the Follow-Up of Patients With Colorectal Liver Metastases. [2021]

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

Gadobenate dimeglumine-enhanced liver MR imaging in cirrhotic patients: quantitative and qualitative comparison of 1-hour and 3-hour delayed images. [2013]

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

Combined SPIO-gadolinium magnetic resonance imaging in cirrhotic patients: negative predictive value and role in screening for hepatocellular carcinoma. [2016]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Cost-Utility Analysis of Non-Contrast Abbreviated Magnetic Resonance Imaging for Hepatocellular Carcinoma Surveillance in Cirrhosis. [2023]

5. United States 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. [2021]

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

Magnetic resonance imaging after arterial portography with manganese dipyridoxal diphosphate. [2019]

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

Hepatocellular carcinoma in patients with chronic liver disease: comparison of SPIO-enhanced MR imaging and 16-detector row CT. [2021]

8. Thailand pubmed.ncbi.nlm.nih.gov

Benefit of double contrast MRI in diagnosis of hepatocellular carcinoma in patients with chronic liver diseases. [2016]

9. India pubmed.ncbi.nlm.nih.gov

Is non-contrast enhanced magnetic resonance imaging cost-effective for screening of hepatocellular carcinoma? [2021]