Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study
To determine the toxicity of the hypoxia PET-tracer [18F]-HX4 in cancer patients in two
- Step 1 (3-6 patients): a single dose of maximum 6 mCi (222 MBq) dose of [18F]HX4 (which
contains a maximum of 15 μg HX-4) via a bolus IV injection.
- Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of [18F]HX4
(which contains a maximum of 27 μg HX-4) via a bolus IV injection.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Toxicity (CTCAE 3.0)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)