A Pilot Study For Patients Receiving Radiation Therapy for Liver Cancer

NCT06144827 | Withdrawn DMC FDA Device

• 1 other identifier: 2023-14687
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer, Hepatocellular; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• Feasibility of Quantitative Multiparametric MRI

  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.

  Up to 12 Months

Secondary Outcomes (3)

• Change in Disease Severity Index (DSI) scores

  Baseline and 3 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 Total Liver Volume and Volume of non-irradiated and irradiated lobes

  Baseline and 3, 6, 9, and 12 Months post-RT

Study Arms (2)

Multiparametric MRI scan group

ACTIVE COMPARATOR

Multiparametric MRI scans will be used to evaluate baseline degree of liver fibroinflammation and function as well as temporal changes in liver fibroinflammation and function using MRI-based LiverMultiScan software.

Device: Multiparametric MRI scans

Multiparametric MRI scans + HepQuantShunt Test group

EXPERIMENTAL

Eligible patients can have previously undergone any modality and number of prior treatments for their hepatic malignancies, must be considered for either liver photon or proton radiation in the de-novo or re-irradiation setting and can be simultaneously enrolled on parallel trials.

Device: Multiparametric MRI scans; Device: Multiparametric MRI scans + HepQuantShunt Test

Interventions

Multiparametric MRI scans DEVICE

Multiparametric MRI scans will be used to evaluate baseline degree of liver fibroinflammation and function as well as temporal changes in liver fibroinflammation and function using MRI-based LiverMultiScan software. We will also measure liver function using HepQuant SHUNT test in a subset of patients enrolled in this study.

Multiparametric MRI scan group; Multiparametric MRI scans + HepQuantShunt Test group

Multiparametric MRI scans + HepQuantShunt Test DEVICE

Eligible patients can have previously undergone any modality and number of prior treatments for their hepatic malignancies, must be considered for either liver photon or proton radiation in the de-novo or re-irradiation setting and can be simultaneously enrolled on parallel trials. Patients must not have any contraindications that would preclude MRI imaging or receipt of HepQuant SHUNT test for those agreeable to have HepQuant SHUNT test.

Multiparametric MRI scans + HepQuantShunt Test group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Related Publications (24)

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MeSH Terms

Conditions

Liver Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Wounds and Injuries

Study Officials

• Rafi Kabbarriti, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 22, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share