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
NCT ID: NCT00110032
Last Updated: 2013-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
46 participants
INTERVENTIONAL
2005-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
conventional surgery
Undergo surgery
positron emission tomography
Undergo PET
fluorine F 18 EF5
Given IV
pharmacological study
Correlative studies
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.
EF5
Given IV
conventional surgery
Undergo surgery
positron emission tomography
Undergo PET
pharmacological study
Correlative studies
Group 3 (EF5, PET)
Patients receive nonradioactive EF5 and \^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.
EF5
Given IV
conventional surgery
Undergo surgery
positron emission tomography
Undergo PET
fluorine F 18 EF5
Given IV
pharmacological study
Correlative studies
Interventions
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EF5
Given IV
conventional surgery
Undergo surgery
positron emission tomography
Undergo PET
fluorine F 18 EF5
Given IV
pharmacological study
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Stephen Michael Hahn
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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UPCC 01304
Identifier Type: -
Identifier Source: secondary_id
CDR0000423313
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02651
Identifier Type: -
Identifier Source: org_study_id
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