Phase 2 N=5 Diagnostic

[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer

Adult Liver Carcinoma · Liver Cirrhosis

Bottom Line

View on ClinicalTrials.gov: NCT02695628 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue — 0.76 Ratio

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 18F-Fluoromisonidazole (Drug); Arterial Embolization (Procedure); Computed Tomography (Diagnostic_test); Positron Emission Tomography (Diagnostic_test)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue	0.76	—
SECONDARY Maximum Standardized Uptake Value (SUVmax) at Lesion Sites With and Without Tumor Recurrence	—	—
SECONDARY Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO)	—	—

Summary

This clinical trial studies how well 18F-fluoromisonidazole ([18F]FMISO) positron emission tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor. [18F]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that have a low level of oxygen, and the radiation given off by [18F]FMISO is picked up by a PET scan and this may help researchers learn whether changes occur in the tumors after treatment, which can help decide how well the treatment worked earlier than is currently possible

Eligibility Criteria

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Histopathologic or imaging and clinical features of tumor(s) diagnostic for hepatocellular carcinoma with at least one tumor >= 1.5 cm; imaging features diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and Data System (LIRADS) 4 or greater
Total bilirubin < 3.0
Child Pugh A or B
Tumor amenable to transcatheter arterial embolization
Able to provide informed consent

Exclusion Criteria

Uncontrolled large ascites
Main or segmental portal vein thrombosis
Locoregional treatment of hepatocellular carcinoma within the prior 3 months or chemotherapy within the previous 3 months
Inability or contraindication to undergo transcatheter arterial embolization
Inability to lay flat for at least 2 consecutive hours
Severe acute illness
Uncontrolled chronic illness such as hypertension, diabetes, or heart failure
Contraindication to CT or MRI contrast
Pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02695628). 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.