Status:
RECRUITING
HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
HepQuant, LLC
Perspectum
Conditions:
Liver Cancer
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 fo...
Detailed Description
Historically, the role of fractionated liver radiation therapy (RT) has been limited because of the potential for developing fatal radiation-induced liver disease (RILD), particularly in patients who ...
Eligibility Criteria
Inclusion
- The following criteria must be met for subjects to be considered for the trial. Additional exclusion criteria must be met for subjects interested in the HepQuant subset of the trial. The first 20 qualifying subjects will be enrolled for the additional HepQuant test.
- 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
- Exclusion criteria for HepQuant SHUNT DuO testing ONLY:
- 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.
Key Trial Info
Start Date :
July 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06899152
Start Date
July 16 2025
End Date
July 1 2031
Last Update
July 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Montefiore Medical Center
The Bronx, New York, United States, 10467