This clinical trial studies ammonia N-13 perfusion positron emission tomography (PET) in measuring the results of tumor ablation in patients with liver cancer. Diagnostic procedures, such as ammonia N-13 perfusion PET, may be able to help doctors determine whether liver tumors were successfully destroyed by heating or freezing procedures (ablations) better than other types of scans, such as computed tomography (CT) or magnetic resonance imaging (MRI).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02018107.
PRIMARY OBJECTIVES:
I. For fludeoxyglucose F 18 (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 ammonia N-13 perfusion (AP)-PET-1(research scan #1) and intra-procedural contrast-enhanced CT (CECT).
II. 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 and intra-procedural CECT fused with FDG PET (FDG PET/CECT).
III. In assessing adequacy of the ablation margin for FDG-avid tumors, the concordance rates of final intra-procedural AP-PET(research scan #1 or #2) with gold standard 24-hour post-procedure MRI or CT will be determined. (Includes patients with renal insufficiency who cannot receive intra-procedural iodinated intravenous [IV] contrast.)
IV. For non-FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: 1) intra-procedural AP-PET-1 fused to pre-procedural MRI or CT and 2) intra-procedural CECT fused to pre-procedural MRI or CT.
V. In assessing adequacy of the ablation margin for non-FDG-avid tumors, the concordance rate of final intra-procedural AP-PET (research scan #1 or #2) fused to pre-procedural MRI or CT with gold standard 24-hour post-procedure MRI or CT will be determined. (Includes patients with renal insufficiency who cannot receive intra-procedural iodinated IV contrast.)
SECONDARY OBJECTIVES:
I. For FDG-avid tumors, rates of local tumor progression based on a minimum of 3-12 month imaging follow-up will be compared for ablation margin adequacy assessed by blinded retrospective reads of final intra-procedural AP-PET (research scan #1 or #2) and 24-hour post-procedure MRI or CT. (Includes patients with renal insufficiency who cannot receive intra-procedural iodinated IV contrast.)
OUTLINE:
Patients undergo ammonia N-13 perfusion PET once or twice (if necessary) on day 1.
After completion of study, patients are followed up every 3 months for at least 1 year.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorPaul Shyn
