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.
Brief Title
A Pilot Study For Patients Receiving Radiation Therapy for Liver Cancer
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Cancer, Hepatocellular
Radiotherapy Side Effect
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06144827
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2023-14687
Overall Status
Withdrawn
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
Primary Outcomes
Outcome Description
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.
Outcome Measure
Feasibility of Quantitative Multiparametric MRI
Outcome Time Frame
Up to 12 Months
Secondary Outcomes
Outcome Description
Change in DSI scores from baseline will be evaluated using HepQuant SHUNT testing. The HepQuant SHUNT test measures hepatocyte function using the Disease Severity Index (DSI). Increased DSI scores have been correlated with worsening liver function and disease severity and progression and response to treatments. The DSI calculation is proprietary; however, the test generates a liver DSI score ranging from 0 (no hepatic impairment) to 50 (severe hepatic impairment) that is a composite of both hepatic filtration rates and correlates with stage of fibrosis, presence of varices, and risk for future clinical outcomes. Raw changes in DSI scoring from baseline scores will be summarized using descriptive statistics and will be examined using a paired t-test or Wilcoxon Sign rank test.
Outcome Time Frame
Baseline and 3 months post-RT
Outcome Measure
Change in Disease Severity Index (DSI) scores
Outcome Description
The ability of LiverMultiScan to predict the risk of non-classic RILD will be evaluated. The pre-radiotherapy liver health assessment score will be calculated by measuring the Future Liver Remnant volume outside the 50% radiation isodose line weighted by the liver cT1 value. MRI images will be post-processed using LiverMultiScan, which provides a multiparametric quantitative map of a region of interest in the liver including characterization of the underlying liver fibroinflammation as reported by a corrected T1 (cT1) value, which will be measured and reported in milliseconds (ms). The likelihood of non-classic RILD based on the cT1 value will be assessed using multivariable logistic regression.
Non-classic RILD is defined as either worsening of Child-Pugh Score by \>=2 points (overall range: 5-15 points) at 6 months following RT or an elevated aminotransferase (ALT or AST) level \> 5 times the upper limit of normal or baseline value within 90 days of completion of RT.
Non-classic RILD is defined as either worsening of Child-Pugh Score by \>=2 points (overall range: 5-15 points) at 6 months following RT or an elevated aminotransferase (ALT or AST) level \> 5 times the upper limit of normal or baseline value within 90 days of completion of RT.
Outcome Time Frame
Baseline to 6 Months post-RT
Outcome 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
Outcome Description
Change in total liver volume, as well as volume of non-irradiated and irradiated liver lobes, from pre-radiotherapy treatment at baseline will be evaluated using Gd-EOB-DTPA enhanced MRI of the abdomen at the specified timeframes to assess the impact of radiotherapy. Mean changes in total liver volume (cm\^3) and volume of non-irradiated and irradiate lobes will be assessed using the MRI software image analysis and summarized by study arm. The data will be analyzed using linear mixed-effects models. Increases in liver volume are correlated to more favorable outcomes
Outcome Time Frame
Baseline and 3, 6, 9, and 12 Months post-RT
Outcome Measure
Change in Total Liver Volume and Volume of non-irradiated and irradiated lobes
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rafi Kabarriti
Investigator Email
RKABARRI@MONTEFIORE.ORG