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

NCT06899152 | Recruiting FDA Device

• 1 other identifier: 2025-16581
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer; Hepatocellular Carcinoma; Hepatocellular Cancer; Cholangiocarcinoma; Liver Metastases

Keywords

Blood-based biomarkers; Quantitative MR imaging; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of Quantitative MRI

  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.

  Approximately 3 months

Secondary Outcomes (4)

• Change in Disease Severity Index (DSI) score

  From baseline to 3 months post-SBRT

• Predictive ability of LiverMultiScan

  6 months post-SBRT

• Change in Total Liver Volume

  From baseline to 3 months, 6 months, 9 months and 12 months post-SBRT

• Change in volume of non-irradiated and irradiated liver lobes

  From baseline to 3 months, 6 months, 9 months and 12 months post-SBRT

Study Arms (2)

Multiparametric MRI scans and HepQuant Duo Test

EXPERIMENTAL

Diagnostic Test: HepQuant DuO; Other: Multiparametric MRI Scans

Multiparametric MRI scans only

ACTIVE COMPARATOR

Other: Multiparametric MRI Scans

Interventions

HepQuant DuO DIAGNOSTIC_TEST

HepQuant DuO is a quantitative liver function test. It assesses cholate uptake, a liver specific function. Cholate is a naturally occurring substance that is cleared by the liver. Cholate uptake reflects the health of liver cells.

Multiparametric MRI scans and HepQuant Duo Test

Multiparametric MRI Scans OTHER

Standard of care

Multiparametric MRI scans and HepQuant Duo Test; Multiparametric MRI scans only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• HepQuant, LLC: collaborator
• Perspectum: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (26)

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  BACKGROUND

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MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Rafi Kabarriti, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafi Kabarriti, MD

CONTACT

718-405-8550; rkbarri@montefiore.org

Rikin Gandhi

CONTACT

rikin.gandhi@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 27, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)