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This is a ten subject, phase 1 study. The purpose of the Phase 1 study is to demonstrate drug safety in a target group of subjects with high grade brain cancer. This population represents a potential clinical population that may benefit from this PET imaging tracer. The study will also begin collection of baseline imaging data and allow us to gain information to improve design and conduct of future trials.
This is a ten subject, phase 1 study. The purpose of the study is to demonstrate drug safety in a group with high grade brain tumors and to evaluate cell proliferation with F-18 FLT. FLT is known to clear out of normal brain and detect brain tumor. This population represents a potential clinical population that may benefit from this PET imaging tracer. This information will help improve the design and conduct of future F-18 FLT clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18 FLT | Drug | One - 10 mci dose of F-18 FLT is administered IV over about 5 seconds prior to PET imaging. Each imaging dose contains no more than 6.1 micrograms of FLT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be demonstrated through analysis of adverse events in subjects enrolled in the trial who received study drug | 24 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles M Intenzo, MD | Thomas Jefferson University Hospital, 132 S 10th St Phila, PA 19107 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C002854 | alovudine |
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|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |