Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study
18 Years
N/A
Both
Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Outcome Measure:
Toxicity (CTCAE 3.0)
Outcome Time Frame:
9 months
Safety Issue:
Yes
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
08-3-040
NCT ID:
NCT00690053
Start Date:
August 2008
Completion Date:
Related Keywords:
- Cancer
- Toxicity
- PET
- HX-4
- cancer
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