[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer
| Status: | Completed |
|---|---|
| Conditions: | Liver Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 1/10/2019 |
| Start Date: | September 13, 2016 |
| End Date: | October 31, 2018 |
Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT
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
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.
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.
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
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Rajesh Shah
Phone: 650-723-0728
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