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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00314 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 0S-12-3 | Other Identifier | USC Norris Comprehensive Cancer Center | |
| P30CA014089 | 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 the safety and drug distribution of the radioactive drug, 2'-deoxy-2'-[18F]fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (fluorine F 18 d-FMAU [18F-FMAU]), for imaging with positron emission tomography/computed tomography (PET/CT) in patients with advanced cancers. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. PET/CT using the drug fluorine F 18 d-FMAU, may help find cancer and find out how far the disease has spread.
PRIMARY OBJECTIVES:
I. To determine the radiation dosimetry of 18F-FMAU in humans, confirm absence of adverse events in humans from intravenous (i.v.) injection of 18F-FMAU for PET imaging, and characterize the incidence of circulating metabolites of 18F-FMAU in humans.
II. To simply find out whether there is any visual uptake change of 18F-FMAU in tumors post-therapy.
OUTLINE:
Patients receive fluorine F 18 d-FMAU IV followed by PET/CT prior to start of cancer treatment. Patients may undergo 2 additional scans at one week prior to second course of chemotherapy and after completion of cancer treatment depending on cancer type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (fluorine F 18 d-FMAU PET/CT scan) | Experimental | Patients receive fluorine F 18 d-FMAU IV followed by PET/CT prior to start of cancer treatment. Patients may undergo 2 additional scans at one week prior to second course of chemotherapy and after completion of cancer treatment depending on cancer type. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorine F 18 d-FMAU | Radiation | Given IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation dosimetry of fluorine F 18 d-FMAU | Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan | |
| Adverse events after injection of fluorine F 18 d-FMAU to the patients | Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan | |
| Fluorine F 18 d-FMAU uptake change in tumors post-therapy | Baseline up to 24 hours after fluorine F 18 d-FMAU PET/CT scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Conti, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 12, 2025 | |
| Reset | Oct 1, 2025 | |
| Release | Jun 5, 2026 | |
| Reset | Jul 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 12, 2025 | Oct 1, 2025 | |||
| Jun 5, 2026 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C034935 | clevudine |
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| positron emission tomography |
| Procedure |
Undergo fluorine F 18 d-FMAU PET/CT scan |
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| computed tomography | Procedure | Undergo fluorine F 18 d-FMAU PET/CT scan |
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| Jul 1, 2026 |