[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer
Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT
4 other identifiers
interventional
5
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2016
CompletedFirst Posted
Study publicly available on registry
March 1, 2016
CompletedStudy Start
First participant enrolled
September 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedResults Posted
Study results publicly available
May 22, 2019
CompletedJanuary 31, 2024
January 1, 2024
1.6 years
February 24, 2016
March 13, 2019
January 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Maximum Standardized Uptake Value (SUVmax) at Lesion Sites With and Without Tumor Recurrence
Up to 6 months
Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO)
18 hours
Study Arms (1)
Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
EXPERIMENTALPatients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
Interventions
Undergo \[18F\] FMISO PET/CT
Undergo transcatheter arterial embolization
Undergo \[18F\] FMISO PET/CT
Undergo \[18F\] FMISO PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
VA Palo Alto Healthcare System
Palo Alto, California, 94304, United States
Related Publications (1)
Shah RP, Laeseke PF, Shin LK, Chin FT, Kothary N, Segall GM. Limitations of Fluorine 18 Fluoromisonidazole in Assessing Treatment-induced Tissue Hypoxia after Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Prospective Pilot Study. Radiol Imaging Cancer. 2022 May;4(3):e210094. doi: 10.1148/rycan.210094.
PMID: 35485937DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rajesh Shah
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Rajesh Shah
Stanford Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2016
First Posted
March 1, 2016
Study Start
September 13, 2016
Primary Completion
April 30, 2018
Study Completion
October 31, 2018
Last Updated
January 31, 2024
Results First Posted
May 22, 2019
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share