Clinical Trial VICCGI1343

Title

Multi-Parametric 3 Tesla Magnetic Resonance Imaging (MRI) of Response to Transarterial Chemoembolization (TACE) in Patients with Hepatocellular Carcinoma (HCC)

Principal Investigator(s)

(David) Lee Gorden

Details

  • Protocol No. VICCGI1343
  • Open Date: 02/06/2014
  • Staging: NA
  • Age Group: Adults
  • Scope: Local
  • Objective: We will determine which (if any) of these parameters correlate with clinical endpoints that are relevant to the treatment of HCC, including: 1. Measurement of tumor size as determined by standard-of-care 1.5 Tesla MR or multidetector-row CT anatomic images acquired per RECISTv1.1 criteria (26). 2. Percentage of viable versus necrotic tumor, based on contrast enhancement characteristics in hepatic arterial phase and portal venous phase images (relative to pre-contrast phase images), as determined by standard-of-care multiphase 1.5 Tesla MR or multidetector-row CT contrast-enhanced images acquired per mRECIST criteria (28). 3. Variables related to the clinical management of HCC, including: the decision to retreat with TACE, the decision to switch to alternate therapy, successful downstaging into transplant eligibility (applies only to the subset of patients who are outside Milan Criteria prior to TACE), serum alpha-fetoprotein (AFP) concentration, time-to-progression (TTP), and overall survival (OS). 4. Baseline HCC disease characteristics, including: histopathological grade of primary tumor, number and size of liver nodules, Child-Pugh score, evidence of portal hypertension. 5. Histopathological features on explanted livers following OLT, including percentage necrosis and cellular density as determined by hematoxylin and eosin staining, extent of fibrosis as determined by collagen staining; correspondence with findings on ex vivo 3T MRI.
  • Disease Sites: Liver
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02057874
  • Secondary Protocol No: Not Specified

Description

Eligibility

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