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Liver Function Study for Patients Receiving Radiation Therapy for Liver Cancer

This study is looking at new ways to measure liver health in people with liver cancer (including hepatocellular carcinoma, cholangiocarcinoma, or liver metastases) who are receiving radiation therapy. Researchers are testing a quantitative liver function test called HepQuant DuO, which measures how well your liver cells clear a natural substance called cholate. They are also using special MRI scans called Multiparametric MRI Scans. The main goal is to see if these MRI scans can effectively monitor liver function before and after radiation therapy. This is a small study aiming to enroll 40 participants, and the first 20 eligible people will also receive the HepQuant test. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 40 participants. It is a pilot and feasibility study.
What's involved
You would undergo Multiparametric MRI Scans. If you are among the first 20 qualifying subjects, you would also receive the HepQuant DuO test.
Compensation
Not stated in the trial record.
Follow-up
The feasibility of Quantitative MRI will be measured at approximately 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06899152

HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer

Recruiting
NAAges 18+InterventionalDiagnostic
Montefiore Medical Center
~40 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:HepQuant DuOMultiparametric MRI Scans

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Quantitative MRI
Measured over Approximately 3 months

Conditions

Liver Cancer
Hepatocellular Carcinoma
Hepatocellular Cancer
Cholangiocarcinoma
Liver Metastases

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CholangiocarcinomaHepatocellular CarcinomaLiver CarcinomaMetastatic Malignant Neoplasm in the Liver

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Rafi Kabarriti, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Rafi Kabarriti, MD
[email protected]
718-405-8550
Email the study team

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Eligibility criteria

Inclusion

Age \> 18
Patient has the psychological ability and general health needed to provide informed consent, completion of study requirements, and required follow-up
Patient provides study-specific informed consent prior to study entry
All primary histologies (Hepatocellular carcinoma or Cholangiocarcinoma) as well as hepatic metastases are eligible
Prior history of radiation therapy (external beam or radioembolization) is allowed, with no limit to the number of prior courses of radiation therapy
Any number of lesions (with no size limit) of pathologically documented (histologically or cytologically) or radiographically proven tumor/metastasis that are being targeted
Prior history of liver resection, transarterial chemoembolization (TACE), or ablation are allowed with no restriction on number of prior therapies, or time from current study registration
Prior history of chemotherapy, immunotherapy, or targeted biological therapy is allowed
Concurrent enrollment on other prospective registry or treatment intention trials is allowed

Exclusion

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
Unable to participate in MR assessments due to physical limitations of equipment tolerances (MRI bore size and/or weight limit)
Any person unable to lie still within the environment of the MRI scanner or maintain a breath hold for the required period to acquire images
Known history or suspected hypersensitivity to human serum albumin, or its preparations
Subjects with extensive resection of large segments of small intestine (short gut) or severe gastroparesis (e.g., diabetic or medication-induced gastroparesis)
Subjects on either a non-selective beta blocker (propranolol, nadolol), or an angiotensin converting enzyme (ACE) inhibitor, or angiotensin receptor blocker (ARB) who are unwilling or unable to delay taking their normal dose the morning of their testing
Subjects who are allergic to any ingredient in the formulations or components in the HepQuant SHUNT DuO kit including the human serum albumin (HSA) or cholate compounds (theoretical - none yet reported)
Subjects unwilling or unable to fast for at least 5 hours. Fasting means no intake of food or food supplements, including fiber preparations or biosimilars; or any preparations or resins (cholestyramine, colestipol, colesevelam) that might act within the gut lumen to bind the orally administered d4-cholate in the HepQuant test.

What this trial measures

  • Feasibility of Quantitative MRIApproximately 3 months

    Feasibility will be determined by assessing the proportion/percentage of participants who complete at least 2 quantitative multiparametric MRI scans following study enrollment. The proportion/percentage of patients will be summarized by study arm using basic descriptive statistics and a Clopper-Pearson 95% exact confidence interval will be determined.