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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00041 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HEP0055 | Other Identifier | OnCore | |
| P30CA124435 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (18F-fluoromisonidazole, PET/CT, embolization) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Fluoromisonidazole | Drug | Undergo [18F] FMISO PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Shah | Stanford Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Healthcare System | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35485937 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) | 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. 18F-Fluoromisonidazole: Undergo [18F] FMISO PET/CT Arterial Embolization: Undergo transcatheter arterial embolization Computed Tomography: Undergo [18F] FMISO PET/CT Positron Emission Tomography: Undergo [18F] FMISO PET/CT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2015 |
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| Arterial Embolization | Procedure | Undergo transcatheter arterial embolization |
|
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| Computed Tomography | Diagnostic Test | Undergo [18F] FMISO PET/CT |
|
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| Positron Emission Tomography | Diagnostic Test | Undergo [18F] FMISO PET/CT |
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| Up to 6 months |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) | 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. 18F-Fluoromisonidazole: Undergo [18F] FMISO PET/CT Arterial Embolization: Undergo transcatheter arterial embolization Computed Tomography: Undergo [18F] FMISO PET/CT Positron Emission Tomography: Undergo [18F] FMISO PET/CT |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Maximum Standardized Uptake Value (SUVmax) in Tumor vs Normal Tissue | Before participants undergo transcatheter arterial embolization (TACE), ie, at baseline, 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 before treatment was assessed as the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR). The data is reported as the mean TLR, with standard deviation. | Mean | Standard Deviation | Ratio |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Due to withdrawal, not all participants completed for this outcome. | Posted | Mean | Standard Deviation | Ratio | 24 hours |
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| 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. | Follow-up 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET) scans at the time of tumor recurrence were not conducted. | Posted | Up to 6 months |
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| 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. | All participants are included for this outcome. | Posted | Number | Number of adverse events | 18 hours |
|
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) | 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. 18F-Fluoromisonidazole: Undergo [18F] FMISO PET/CT Arterial Embolization: Undergo transcatheter arterial embolization Computed Tomography: Undergo [18F] FMISO PET/CT Positron Emission Tomography: Undergo [18F] FMISO PET/CT | 0 | 5 | 0 | 5 | 5 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations -Other, Cellulitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatobiliary disorders -Other, increased liver functions | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Shah | Stanford University | 650-723-0728 | rajshah@stanford.edu |
| Mar 8, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C031843 | fluoromisonidazole |
| D014057 | Tomography, X-Ray Computed |
| D014054 | Tomography |
| D049268 | Positron-Emission Tomography |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014055 | Tomography, Emission-Computed |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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