drugset / Trial / NCT01246869

Assessment of Primary and Metastatic Brain Tumor Hypoxia With Fluoromisonidazole, FDG and Water

NCT01246869

Phase 1 Terminated 2 enrolled University of Utah
NaSingle-groupOpen-labelDiagnostic

Summary

Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole) in patients with (1) newly diagnosed primary malignant brain tumors (WHO \[World Health Organization\] Grade III or IV glial-based tumors) who have not had a complete surgical resection and by contrast MRI (Magnetic resonance imaging) have residual tumor \> 1.0 cm in diameter and will be receiving radiotherapy or (2) newly diagnosed brain metastasis (\> 1.0 cm in diameter who will be receiving radiotherapy. The ability to accurately assess tumor hypoxia and accurately determine the amount/degree of tumor hypoxia could potentially change patient management once validated as tumor hypoxia is known to be associated with a poor prognosis \[Eyler 2008\].

Timeline

Start
2013-03-27
Primary completion
2014-05-03
Completion
2014-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject 15O-water Diagnostic / imaging agent
Subject F-MISO Diagnostic / imaging agent
Subject [18F]fluoro-2-deoxy-D-glucose Diagnostic / imaging agent

Indications