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

Liver Cirrhosis Clinical Trial

Official title:

Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695628
• Other study ID #: IRB-29768
• Secondary ID: NCI-2016-00041HE
• Status: Completed
• Phase: Phase 2
• Start date: September 13, 2016
• Est. completion date: October 31, 2018

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

PRIMARY OBJECTIVES:

I. Determine the variability of 18F FMISO uptake in hepatocellular carcinoma (HCC) tumors compared to normal liver after transcatheter arterial embolization by determining the difference in the mean of the maximum standardized uptake value (SUVmax) and tumor-to-liver ratio (TLR) of a region of normal liver and of up to 5 index tumors.

SECONDARY OBJECTIVES:

I. Determine if areas of tumor recurrence as determined by CT or magnetic resonance imaging (MRI) within a 6 month period after transcatheter arterial embolization show evidence of increased 18F FMISO labeling on the initial post treatment 18F FMISO PET/CT.

II. Determine the variability in SUVmax and TLR of untreated (non embolized) HCC lesions compared to normal liver by determining the difference in the mean of the SUVmax and TLR of normal liver and tumor.

III. Determine any toxicities related to [18F]FMISO use for PET/CT.

OUTLINE:

Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole intravenously (IV) and undergo PET/CT scans within 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.

After completion of treatment, patients are followed up at 2 and 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Liver Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular
• Liver Cirrhosis

Intervention

Drug:
• 18F-Fluoromisonidazole
Undergo [18F] FMISO PET/CT

Procedure:
• Arterial Embolization
Undergo transcatheter arterial embolization

Diagnostic Test:
• Computed Tomography
Undergo [18F] FMISO PET/CT
• Positron Emission Tomography
Undergo [18F] FMISO PET/CT

Locations

Country	Name	City	State
United States	VA Palo Alto Healthcare System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue	All participants undergo transcatheter arterial embolization (TACE) and 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were conducted. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake in hepatocellular carcinoma (HCC) tumors post-TACE was assessed as the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR). The outcome is reported as the mean TLR, with standard deviation.	24 hours
Secondary	Maximum Standardized Uptake Value (SUVmax) at Lesion Sites With and Without Tumor Recurrence	Follow-up 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were to be conducted within 6 months or at the time of tumor recurrence. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake at the hepatocellular carcinoma (HCC) tumor lesion site post-TACE was assessed as the mean difference in the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR), between lesions that recurred, and those that did not. The outcome is reported as the mean TLR, with standard deviation.	Up to 6 months
Secondary	Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO)	Toxicity to 18F-fluoromisonidazole (18F-FMISO) was assessed by the number of adverse events that occurred within 18 hours of administration (about 10 half-lives), that were also unanticipated and related to 18F-FMISO. The outcome is reported as the number of adverse events that were unanticipated and related to 18F-FMISO, a number without dispersion.	18 hours