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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)

Lee (David) Gorden

Details

  • Protocol No. VICCGI1343
  • Open Date: 02/06/2014
  • Staging: N/A
  • 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

None Provided.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Subjects must have signed an institutional review board (IRB)-approved informed consent document
• Subjects must have verified unresectable hepatocellular carcinoma (HCC), diagnosed on the basis of clinical and imaging criteria
• Subjects must be classified as TNM stage I, II, or III; alternatively, subjects may be classified as Barcelona Clinic Liver Cancer (BCLC) stage A or B
• Subjects must be scheduled to undergo transarterial chemoembolization (TACE)
• Subjects must have at least 1 lesion being targeted by TACE that is > 2 cm in the longest cross-sectional (axial plane) diameter
• Subjects must satisfy one of the following conditions pertaining to their eligibility to undergo orthotopic liver transplantation (OLT):
• HCC that is within Milan Criteria, i.e., TACE is indicated as a "bridge" to OLT (Group I); or
• HCC that is outside Milan Criteria, i.e., TACE is indicated as a means of "down-staging" into transplant eligibility (Group II)
Exclusion Criteria:
• Subjects who have received prior treatment for HCC (prior surgical procedures not related to HCC are allowed)
• Subjects who have undergone prior radioembolization
• Subjects with a central venous line
• Subjects who have any type of biomedical implant, device and/or ferromagnetic material that can be displaced, perturbed, or otherwise malfunction due to mechanical, electronic, or magnetic means; these items may include:
• Metallic fragments or shrapnel (such as from war wounds)
• Cerebral aneurysm clips, biopsy marker clips
• Vascular access ports (as are used with intravenous chemotherapy)
• Cochlear implants, pacemakers, neurostimulators, biostimulators, and electronic infusion pumps **Implanted materials other than those verified as being rated "magnetic resonance [MR] Safe" or "MR Conditional 6" will not be allowed on study
• Creatinine >= 1.5 times upper limit of normal
• Estimated glomerular filtration rate (eGFR) < 30 mL/min
• Subjects who are pregnant or nursing
• Subjects who have had past allergic or other adverse reactions to intravenous injection of Magnevist® (gadopentetate dimeglumine) or other gadolinium-containing contrast agents
• Subjects who exhibit noticeable anxiety, claustrophobia, or vertigo when moved into the scanner
• Subjects incapable of giving informed written consent, for the following reasons:
• Inability to adhere to the experimental protocols for any reason
• Inability to communicate with the research team
• Mental disability, altered mental status, confusion, or psychiatric disorders
• Prisoners or others susceptible to coercion