TheranosticTrials.org

Clinical Trial · NCT02018107

PET/CT-Assessment of Liver Tumor Ablation

Overview

In this research study, the investigators are evaluating whether ammonia PET scans or FDG PET perfusion scans are more useful in helping radiologists determine whether liver tumors were successfully destroyed by the heating or freezing procedures (ablations) than other scans currently available to radiologists, such as CT scans and MRI scans. The currently available scan (usually a CT scan with contrast dye) is not always effective in showing how completely the tumor has been destroyed. The ammonia PET scan is a different way of looking at how much tumor has been destroyed. This study will compare the standard scan (CT scan) with the ammonia PET scan.

Sponsor

Dana-Farber Cancer Institute

Phase

N/A

Contacts

Paul B. Shyn, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02018107

Drug / Compound

ammonia

Isotope(s):
Target(s):
  • No Explicit Target
Ligand Class: Small Molecules

fluorodeoxyglucose

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Liver tumor ablation judged to be appropriate based on clinical assessment in the BWH (Brigham \& Women's Hospital) Tumor Ablation Clinic by the tumor ablation interventional radiologist, per standard clinical practice
  • ECOG (Eastern Cooperative Oncology Group) Performance Status \< 3
  • Referral from an internist, oncologist, or surgeon for liver tumor ablation consultation

Exclusion

  • Severe renal insufficiency, EGFR (estimated glomerular filtration rate) \< 30
  • Pulmonary disease precluding monitored anesthesia care or general anesthesia
  • Childs-Pugh Class C cirrhosis
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Uncorrectable coagulopathy (due to bleeding risk)
  • Occlusive main portal vein thrombosis
  • Pregnant women are excluded (because both CT and PET/CT scans involve the use of ionizing radiation which may pose a potential teratogenic effect on the fetus.)
  • Presence of biliary-enteric anastomosis (due to risk of biliary infection)