RECRUITING

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

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Conditions

Liver CancerHepatocellular CarcinomaHepatocellular CancerCholangiocarcinomaLiver MetastasesBlood-based biomarkersQuantitative MR imagingRadiotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05
Study Completion:2031-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06899152

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18
  2. * Patient has the psychological ability and general health needed to provide informed consent, completion of study requirements, and required follow-up
  3. * Patient provides study-specific informed consent prior to study entry
  4. * All primary histologies (Hepatocellular carcinoma or Cholangiocarcinoma) as well as hepatic metastases are eligible
  5. * Prior history of radiation therapy (external beam or radioembolization) is allowed, with no limit to the number of prior courses of radiation therapy
  6. * Any number of lesions (with no size limit) of pathologically documented (histologically or cytologically) or radiographically proven tumor/metastasis that are being targeted
  7. * 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
  8. * Prior history of chemotherapy, immunotherapy, or targeted biological therapy is allowed
  9. * Concurrent enrollment on other prospective registry or treatment intention trials is allowed
  1. * Pregnant or breast-feeding females
  2. * Subjects with history of claustrophobia impacting ability to perform MRI during the study
  3. * 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
  4. * Unable to participate in MR assessments due to physical limitations of equipment tolerances (MRI bore size and/or weight limit)
  5. * 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
  6. * Known history or suspected hypersensitivity to human serum albumin, or its preparations
  7. * Subjects with extensive resection of large segments of small intestine (short gut) or severe gastroparesis (e.g., diabetic or medication-induced gastroparesis)
  8. * 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
  9. * 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)
  10. * 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.

Contacts and Locations

Study Contact

Rafi Kabarriti, MD
CONTACT
718-405-8550
rkbarri@montefiore.org
Rikin Gandhi
CONTACT
rikin.gandhi@einsteinmed.edu

Principal Investigator

Rafi Kabarriti, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10467
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • Rafi Kabarriti, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2031-05

Study Record Updates

Study Start Date2025-05
Study Completion Date2031-05

Terms related to this study

Keywords Provided by Researchers

  • Blood-based biomarkers
  • Quantitative MR imaging
  • Radiotherapy

Additional Relevant MeSH Terms

  • Liver Cancer
  • Hepatocellular Carcinoma
  • Hepatocellular Cancer
  • Cholangiocarcinoma
  • Liver Metastases