Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain Tumors
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
- 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.
-
Determine the ability of positron emission tomography (PET) scanning using ^18F-EF5 to detect tumor hypoxia in these patients.
-
Determine the presence and pattern of nonradioactive EF5 binding by immunohistochemistry (IHC) and/or flow cytometry in these patients.
-
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 (fluorine F 18 EF5, PET) 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. |
Procedure: conventional surgery
Undergo surgery
Other Names:
Procedure: positron emission tomography
Undergo PET
Other Names:
Radiation: fluorine F 18 EF5
Given IV
Other Names:
Other: pharmacological study
Correlative studies
Other Names:
|
| Experimental: Group 2 (EF5, PET) Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning. |
Drug: EF5
Given IV
Procedure: conventional surgery
Undergo surgery
Other Names:
Procedure: positron emission tomography
Undergo PET
Other Names:
Other: pharmacological study
Correlative studies
Other Names:
|
| Experimental: Group 3 (EF5, PET) Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning. |
Drug: EF5
Given IV
Procedure: conventional surgery
Undergo surgery
Other Names:
Procedure: positron emission tomography
Undergo PET
Other Names:
Radiation: fluorine F 18 EF5
Given IV
Other Names:
Other: pharmacological study
Correlative studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety of F-18-EF5 based on the NCI CTCAE version 3.0 [Up to 3 years]
Summarized in descriptive statistics.
Secondary Outcome Measures
- 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 [Up to day 1]
- Progression-free survival [Up to 6 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed and/or clinical and imaging evidence of a de novo mass that is likely to be a brain tumor
-
Amenable to debulking surgery or surgical resection or biopsy as standard initial therapy for the tumor
-
Performance status - Karnofsky 70-100%
-
At least 3 months
-
WBC count ≥ 2,000/mm^3
-
Platelet count ≥ 100,000/mm^3
-
Bilirubin < 1.2 mg/dL
-
Creatinine < 1.3 mg/dL
-
No symptomatic congestive heart failure
-
No unstable angina pectoris
-
No cardiac arrhythmia
-
No other significant cardiac condition that would preclude study participation
-
Not pregnant or nursing
-
Negative pregnancy test
-
Fertile patients must use effective contraception during and for 1 month after study participation
-
Weight ≤ 130 kg
-
No peripheral neuropathy ≥ grade 3
-
No history of allergic reaction attributed to metronidazole
-
No other uncontrolled illness
-
No psychiatric illness or social situation that would preclude study compliance
-
No other medical condition that would preclude study participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Stephen Michael Hahn, Abramson Cancer Center of the University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2012-02651
- UPCC 01304
- CDR0000423313