Status:
COMPLETED
Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET)
Lead Sponsor:
Maastricht Radiation Oncology
Collaborating Sponsors:
Amsterdam UMC, location VUmc
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 dru...
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 conta...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00690053
Start Date
August 1 2008
Last Update
June 30 2009
Active Locations (1)
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1
Maastricht Radiation Oncology (MAASTRO clinic)
Maastricht, Netherlands, 6229 ET