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

Summary

This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary histology, that are undergoing photon radiation either in the de-novo or re-irradiation setting. The goal of this study is to prospectively evaluate the feasibility of using quantitative multiparametric MRI to monitor liver function at baseline and following liver radiation therapy.

Eligibility

The following criteria must be met for subjects to be considered for the trial. Additional exclusion criteria must be met for subjects interested in the HepQuant subset of the trial. The first 20 qualifying subjects will be enrolled for the additional HepQuant test.

Inclusion Criteria:

* Age \> 18
* 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 liver resection, transarterial chemoembolization (TACE), or ablation are allowed with no restriction on number of prior therapies, or time from current study registration
* 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 DuO 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 (e.g., diabetic or medication-induced 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 DuO kit including the 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, colesevelam) that might act within the gut lumen to bind the orally administered d4-cholate in the HepQuant test.

Conditions7

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