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

Montefiore Medical Center0 sites40 target enrollmentJanuary 2025

ConditionsCancer, Hepatocellular Radiotherapy Side Effect

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer, Hepatocellular
Sponsor: Montefiore Medical Center
Enrollment: 40
Primary Endpoint: Feasibility of Quantitative Multiparametric MRI
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2025

End Date

January 2028

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Montefiore Medical Center

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

Feasibility of Quantitative Multiparametric MRI

Time Frame: Up to 12 Months

Feasibility will be determined by assessing the percentage of patients who complete at least two quantitative multiparametric MRI scans after study enrollment. The feasibility endpoint will be presented as proportions and a Clopper Pearson 95% exact confidence interval will be determined.

Secondary Outcomes

Change in Total Liver Volume and Volume of non-irradiated and irradiated lobes(Baseline and 3, 6, 9, and 12 Months post-RT)
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(Baseline to 6 Months post-RT)
Change in Disease Severity Index (DSI) scores(Baseline and 3 months post-RT)