HepQuant: Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
Montefiore Medical Center
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.
Description
Historically, the role of fractionated liver radiation therapy (RT) has been limited because of the potential for developing fatal radiation-induced liver disease (RILD), particularly in patients who already have poor liver function due to cirrhosis. Classic RILD generally occurs within 4 months following radiotherapy to the liver and consists of symptoms including fatigue, right upper quadrant pain, ascites, anicteric hepatomegaly, and elevation of liver enzymes especially alkaline phosphatase. Technical advances in the delivery of RT, particularly using stereotactic body radiotherapy (SBRT)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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)…
Interventions
- Diagnostic TestHepQuant DuO
HepQuant DuO is a quantitative liver function test. It assesses cholate uptake, a liver specific function. Cholate is a naturally occurring substance that is cleared by the liver. Cholate uptake reflects the health of liver cells.
- OtherMultiparametric MRI Scans
Standard of care
Location
- Montefiore Medical CenterThe Bronx, New York