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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01196 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2016-0847 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This early phase I trial studies how well 18F-fluoroazomycin arabinoside positron emission tomography (PET)-computed tomography (CT) works in diagnosing solid tumors. Using 18F-fluoroazomycin arabinoside with PET-CT may help doctors plan better treatment for patients with solid tumors. 18F-fluoroazomycin arabinoside may help to show how much oxygen is present in a tumor during a PET-CT scan.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of PET-CT using 18F-fluoroazomycin arabinoside ([18F]FAZA) and to determine the optimal imaging time to detect hypoxia in solid tumors.
SECONDARY OBJECTIVES:
I. To determine the variability of imaging findings from repeated [18F]FAZA PET-CT studies over >= 24 hours up to 10 days.
II. To confirm the safety of [18F]FAZA administered during PET-CT imaging of hypoxia of solid tumors.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients receive 18F-fluoroazomycin arabinoside intravenously (IV) and after 60 minutes undergo 5 PET-CT scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2.
GROUP B: Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 or less PET-CT scans on day 1 and 5 or less PET-CT scans >= 24 hours later up to 10 days.
After completion of study treatment, patients are followed up at 24 hours and at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (18F-fluoroazomycin arabinoside, PET-CT scans) | Experimental | Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 PET-CT scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2. |
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| Group B (18F-fluoroazomycin arabinoside, PET-CT scans) | Experimental | Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 or less PET-CT scans on day 1 and 5 or less PET-CT scans >= 24 hours later up to 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET-CT scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative change of imaging parameters (tumor volume, standardized uptake value [SUV], tumor to muscle ratio [TMR], hypoxic tumor volume [HTV1, HTV2], and total lesion hypoxia [TLH1, TLH2]) | Summary statistics of tumor volume, SUV, TMR, HTV1, HTV2, TLH1, TLH2, and their changes from baseline to later time point will be provided in mean, standard deviation, and range by time point. Lin's concordance correlation coefficient for these parameters will be calculated and MDC95 will also be calculated for 2 hour timepoint or other time points. Other statistical analyses will be carried out as appropriate. | Baseline up to 30 days |
| Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.03 | Adverse events and vital signs will be monitored and described with descriptive statistics. | Up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franklin C Wong | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Fluorine F 18-fluoroazomycin Arabinoside | Radiation | Given IV |
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| Positron Emission Tomography | Procedure | Undergo PET-CT scan |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C498052 | fluoroazomycin arabinoside |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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