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PET/CT-Assessment of Liver Tumor Ablation

Status: Recruiting
Phase: N/A
Diagnosis: Gastrointestinal Malignancies, Colorectal Cancer
NCT ID: NCT02018107 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-464

 

In this research study, the investigators are evaluating whether ammonia PET 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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Paul Shyn, M.D., Brigham and Women's Hospital

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

Inclusion Criteria: - Adults, 18 years or older - Referral from an internist, oncologist, or surgeon for liver tumor ablation consultation - ECOG (Eastern Cooperative Oncology Group) Performance Status < 3 - 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 - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Uncorrectable coagulopathy (due to bleeding risk) - Pulmonary disease precluding monitored anesthesia care or general anesthesia - Severe renal insufficiency, EGFR (estimated glomerular filtration rate) < 30 - 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. - Childs-Pugh Class C cirrhosis - Occlusive main portal vein thrombosis - Presence of biliary-enteric anastomosis (due to risk of biliary infection) - 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.)
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