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Clinical Trial · NCT00110032
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
Overview
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
Sponsor
National Cancer Institute
Phase
Phase 1
Contacts
Stephen Michael Hahn (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT00110032Drug / Compound
EF5
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Hypoxia
Ligand Class: Small Molecules
Eligibility
Inclusion
- 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
- * Histologically confirmed and/or clinical and imaging evidence of a de novo mass that is likely to be a brain tumor
- WBC count ≥ 2,000/mm\^3
Exclusion
Exclusion criteria not yet provided.
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