N/A
N=27
PET/CT-Assessment of Liver Tumor Ablation
Liver Tumor · Liver Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02018107 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: 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) — 42; 40; 25 Tumors
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- N-13 ammonia or F-18 fluorodeoxyglucose (Diagnostic_test); PET scan (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
42; 40; 25 | — |
| SECONDARY Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI? |
53.84; 83.33; 96.29; 89.47 | — |
Summary
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.
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.)
Data sourced from ClinicalTrials.gov (NCT02018107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.