Liver Neoplasms Clinical Trial
Official title:
PET/CT-Guided Liver Tumor Ablation: Intraprocedural Assessment of Results Using Ammonia Perfusion PET
NCT number | NCT02018107 |
Other study ID # | 13-464 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | February 16, 2019 |
Verified date | March 2020 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | February 16, 2019 |
Est. primary completion date | February 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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.) |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and Percentage of Tumors With Complete, Circumferential Ablation Margin Visibility During FDG PET/CT-guided Liver Ablations (AP-PET-1 v. Contrast-enhanced MRI) | For FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: intra-procedural AP-PET-1(research scan #1) and post-procedural contrast enhanced MRI . Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated. | 2 Years | |
Secondary | Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI? | Percentage of tumors with an inadequate margin on PET that progressed locally? Compare to MRI? | 2 Years |
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