Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Maastricht Radiation Oncology
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Toxicity (CTCAE 3.0)
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options.
- •Normal white blood cell count and neutrophils
- •Normal platelet count
- •No anaemia requiring blood transfusion or erythropoietin
- •Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution).
- •Calculated Creatinin clearance at least 60 ml/min
- •No administration of Fluor-18 in the previous 24 hours
- •Capable of complying with study procedures
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Toxicity (CTCAE 3.0)
Time Frame: 9 months
Secondary Outcomes
- Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan)(9 months)