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

January 15, 2013 updated by: National Cancer Institute (NCI)

Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Procedure: conventional surgery
Undergo surgery
Other Names:
  • surgery, conventional
Procedure: positron emission tomography
Undergo PET
Other Names:
  • PET
  • FDG-PET
  • PET scan
  • tomography, emission computed
Radiation: fluorine F 18 EF5
Given IV
Other Names:
  • 18F-EF5
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.
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Procedure: conventional surgery
Undergo surgery
Other Names:
  • surgery, conventional
Drug: EF5
Given IV
Procedure: positron emission tomography
Undergo PET
Other Names:
  • PET
  • FDG-PET
  • PET scan
  • tomography, emission computed
Experimental: Group 3 (EF5, PET)
Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Procedure: conventional surgery
Undergo surgery
Other Names:
  • surgery, conventional
Drug: EF5
Given IV
Procedure: positron emission tomography
Undergo PET
Other Names:
  • PET
  • FDG-PET
  • PET scan
  • tomography, emission computed
Radiation: fluorine F 18 EF5
Given IV
Other Names:
  • 18F-EF5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of F-18-EF5 based on the NCI CTCAE version 3.0
Time Frame: Up to 3 years
Summarized in descriptive statistics.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Up to 6 years
Up to 6 years
Pharmacokinetics of radioactively labeled [F-18]-EF5
Time Frame: Day 1
Day 1
Extent of hypoxia, determined by [F-18]-EF5 PET imaging
Time Frame: Up to day 1
Up to day 1
IHC analysis of cold EF5
Time Frame: Up to day 1
Up to day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

May 3, 2005

First Submitted That Met QC Criteria

May 3, 2005

First Posted (Estimate)

May 4, 2005

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02651
  • UPCC 01304
  • CDR0000423313 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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