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| ID | Type | Description | Link |
|---|---|---|---|
| UPCC 01304 | |||
| CDR0000423313 | Registry Identifier | PDQ (Physician Data Query) |
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Administratively complete.
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This phase I trial is studying the side effects of fluorine F18 EF5 when given during positron emission tomography to find oxygen in tumor cells of patients who are undergoing surgery or biopsy for newly diagnosed brain tumors. Diagnostic procedures using fluorine F 18 EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer treatment
PRIMARY OBJECTIVES:
I. Determine the safety of fluorine F 18 EF5 (^18F-EF5) in patients with newly diagnosed brain tumors undergoing surgery or biopsy.
Secondary I. Determine the pharmacokinetics and biodistribution of ^18F-EF5 administered before and after nonradioactive EF5 in these patients.
II. Determine the ability of positron emission tomography (PET) scanning using ^18F-EF5 to detect tumor hypoxia in these patients.
III. Determine the presence and pattern of nonradioactive EF5 binding by immunohistochemistry (IHC) and/or flow cytometry in these patients.
IV. Correlate tumor hypoxia, as measured by PET scanning using ^18F-EF5, with EF5 staining by IHC and/or flow cytometry and recurrence-free survival of these patients.
OUTLINE: Patients are assigned to 1 of 3 groups.
Group 1: Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole body positron emission tomography (PET) scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.
Group 2: Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.
Group 3: Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning. Approximately one day after EF5 administration, all patients undergo surgery or biopsy of the tumor AND biopsy of normal skin adjacent to the incision.
Patients are followed at 2-4 weeks and 4-6 weeks after EF5 administration and then every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (fluorine F 18 EF5, PET) | Experimental | Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole body PET scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours. |
|
| Group 2 (EF5, PET) | Experimental | Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning. |
|
| Group 3 (EF5, PET) | Experimental | Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EF5 | Drug | Given IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of F-18-EF5 based on the NCI CTCAE version 3.0 | Summarized in descriptive statistics. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of radioactively labeled [F-18]-EF5 | Day 1 | |
| Extent of hypoxia, determined by [F-18]-EF5 PET imaging | Up to day 1 | |
| IHC analysis of cold EF5 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Michael Hahn | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| conventional surgery |
| Procedure |
Undergo surgery |
|
|
| positron emission tomography | Procedure | Undergo PET |
|
|
| fluorine F 18 EF5 | Radiation | Given IV |
|
|
| pharmacological study | Other | Correlative studies |
|
|
| Up to day 1 |
| Progression-free survival | Up to 6 years |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D004806 | Ependymoma |
| D009837 | Oligodendroglioma |
| D016545 | Choroid Plexus Neoplasms |
| D003397 | Craniopharyngioma |
| D018242 | Neuroectodermal Tumors, Primitive |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D008579 | Meningioma |
| D008527 | Medulloblastoma |
| D005910 | Glioma |
| D010871 | Pinealoma |
| D018315 | Glioma, Subependymal |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D002551 | Cerebral Ventricle Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D003226 | Congresses as Topic |
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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