Clinical trial NCT06144827: A Pilot Study For Patients Receiving Radiation Therapy for Liver Cancer
Official title: Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer, Hepatocellular
Radiotherapy Side Effect
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: HepQuant, LLC
name: Perspectum
First posted: 2023-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the role of quantitative MR imaging and blood-based biomarkers to measure liver function in patients receiving radiation therapy for liver cancer or cancer that has spread to the liver.

Detailed description: The purpose of this study is to evaluate the role of quantitative MR imaging and blood-based biomarkers to measure liver function in patients receiving radiation therapy for liver cancer or cancer that has spread to the liver. The feasibility of using MR imaging to monitor liver function at baseline and following liver radiation therapy will be determined. Information from MR images and blood samples, along with patient questionnaires, will be used.

Eligibility criteria: Inclusion Criteria:

* 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 chemotherapy, immunotherapy, or targeted biological therapy is allowed
* Concurrent enrollment on other prospective registry or treatment intention trials is allowed

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
* 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 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
* 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 kit including 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, colesalvalem) that might act within the gut lumen to bind the orally administered d4-cholate in the HepQuant test

Primary outcomes:
measure: Feasibility of Quantitative Multiparametric MRI
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Change in Disease Severity Index (DSI) scores
timeFrame: Baseline and 3 months post-RT
measure: Ability of LiverMultiScan™ MRI software to predict the risk of non-classic radiation-induced liver disease (RILD) by measuring the pre-RT liver health assessment score
timeFrame: Baseline to 6 Months post-RT
measure: Change in Total Liver Volume and Volume of non-irradiated and irradiated lobes
timeFrame: Baseline and 3, 6, 9, and 12 Months post-RT
Other outcomes:
Locations:
Study officials:
affiliation: Montefiore Medical Center
name: Rafi Kabbarriti, MD
role: PRINCIPAL_INVESTIGATOR
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