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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Etanidazole; Fluorides

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