Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) (HX-4)
Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in patients. However, bad image quality and unpredictable kinetics limit their use. In extensive pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic new probe to determine hypoxia.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
|Official Title:||Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study|
- Toxicity (CTCAE 3.0) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Procedure: Injection of HX-4
In step 1: 1 injection of HX-4 (max.6mCi (222MBq)) In step 2: 1 injection of HX-4 (max.12mCi 444MBq)
To determine the toxicity of the hypoxia PET-tracer [18F]-HX4 in cancer patients in two dose-steps:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690053
|Maastricht Radiation Oncology (MAASTRO clinic)|
|Maastricht, Netherlands, 6229 ET|