Adult Liver Carcinoma, Liver Cirrhosis
Conditions
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.
Interventions
Undergo \[18F\] FMISO PET/CT
PROCEDUREArterial Embolization
Undergo transcatheter arterial embolization
DIAGNOSTIC_TESTComputed Tomography
Undergo \[18F\] FMISO PET/CT
DIAGNOSTIC_TESTPositron Emission Tomography
Undergo \[18F\] FMISO PET/CT
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue | 24 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO) | 18 hours | 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. |
| Maximum Standardized Uptake Value (SUVmax) at Lesion Sites With and Without Tumor Recurrence | Up to 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 66.6 Years STANDARD_DEVIATION 5.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Maximum Standardized Uptake Value (SUVmax) in Tumor vs Normal Tissue | 0.71 Ratio STANDARD_DEVIATION 0.22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: 24 hours
Population: Due to withdrawal, not all participants completed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) | Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue | 0.76 Ratio | Standard Deviation 0.14 |
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.
Time frame: 18 hours
Population: All participants are included for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) | Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO) | 0 Number of adverse events |
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.
Time frame: Up to 6 months
Population: Follow-up 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET) scans at the time of tumor recurrence were not conducted.