[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer
Primary Purpose
Adult Liver Carcinoma, Liver Cirrhosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-Fluoromisonidazole
Arterial Embolization
Computed Tomography
Positron Emission Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Adult Liver Carcinoma
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
Sites / Locations
- VA Palo Alto Healthcare System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
Arm Description
Patients 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02695628
First Posted
February 24, 2016
Last Updated
May 1, 2019
Sponsor
Sanjiv Sam Gambhir
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02695628
Brief Title
[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer
Official Title
Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 13, 2016 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sanjiv Sam Gambhir
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Liver Carcinoma, Liver Cirrhosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
Arm Type
Experimental
Arm Description
Patients 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.
Intervention Type
Drug
Intervention Name(s)
18F-Fluoromisonidazole
Other Intervention Name(s)
18F-MISO, 18F-Misonidazole, FMISO
Intervention Description
Undergo [18F] FMISO PET/CT
Intervention Type
Procedure
Intervention Name(s)
Arterial Embolization
Other Intervention Name(s)
TAE, Transarterial Embolization
Intervention Description
Undergo transcatheter arterial embolization
Intervention Type
Diagnostic Test
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Intervention Description
Undergo [18F] FMISO PET/CT
Intervention Type
Diagnostic Test
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo [18F] FMISO PET/CT
Primary Outcome Measure Information:
Title
Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Maximum Standardized Uptake Value (SUVmax) at Lesion Sites With and Without Tumor Recurrence
Description
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.
Time Frame
Up to 6 months
Title
Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO)
Description
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.
Time Frame
18 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Shah
Organizational Affiliation
Stanford Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Healthcare System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35485937
Citation
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.
Results Reference
derived
Learn more about this trial
[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer
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