Clinical trial · Interventional
PET/CT-Assessment of Liver Tumor Ablation
PET/CT-Guided Liver Tumor Ablation: Intraprocedural Assessment of Results Using Ammonia Perfusion PET
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Liver Tumor | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N-13 ammonia or F-18 fluorodeoxyglucose | Diagnostic Test | — | UNRESOLVED |
| PET scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- N-13 ammonia to image liver PET perfusion
- description
- This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only
- interventionNames
- Diagnostic Test: N-13 ammonia or F-18 fluorodeoxyglucose
- Diagnostic Test: PET scan
Primary outcomes (1)
- measure
- 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)
- timeFrame
- 2 Years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (1)
- DERIVEDShyn PB, Cubre AJ, Catalano PJ, Lee LK, Hyun H, Tuncali K, Seol JG, Levesque VM, Gerbaudo VH, Kapur T, Chao RT, Silverman SG. F-18 FDG perfusion PET: intraprocedural assessment of the liver tumor ablation margin. Abdom Radiol (NY). 2021 Jul;46(7):3437-3447. doi: 10.1007/s00261-021-02970-8. Epub 2021 Feb 19. PMID 33606061