A Pilot Study For Patients Receiving Radiation Therapy for Liver Cancer
NCT ID: NCT06144827
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-01-31
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Multiparametric MRI scan group
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.
Multiparametric MRI scans
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 scans + HepQuantShunt Test group
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.
Multiparametric MRI scans
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 scans + HepQuantShunt Test
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.
Interventions
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Multiparametric MRI scans
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 scans + HepQuantShunt Test
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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HepQuant, LLC
INDUSTRY
Perspectum
INDUSTRY
Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Rafi Kabbarriti, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
References
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Other Identifiers
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2023-14687
Identifier Type: -
Identifier Source: org_study_id
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