Status:
WITHDRAWN
Non-invasive Imaging With [18F]VM4-037
Lead Sponsor:
Maastricht Radiation Oncology
Collaborating Sponsors:
Maastricht University Medical Center
Conditions:
Stage 4 Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the toxicity of the hypoxia PET-tracer \[18F\]-VM4-037 in cancer patients in two dose-steps: * Step 1 (3-6 patients): a single dose of maximum 8 mCi (296 MBq...
Eligibility Criteria
Inclusion
- Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options
- WHO performance status 0 to 1
- Normal white blood cell count and formula
- 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
- The patient is capable of complying with study procedures
- 18 years or older
Exclusion
- Only visible tumor sites in the upper abdomen (because the uptake of VM4-037 in the liver, stomach and the kidneys would interfere with image quality of the tumor)
- Known hypersensitivity for sulfonamides
- Recent (\< 3 months) myocardial infarction
- Uncontrolled infectious disease
- Less than 18 years old
- Pregnancy
- No concurrent anti-cancer agents or radiotherapy allowed
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00935142
Start Date
January 1 2012
End Date
November 1 2012
Last Update
January 25 2013
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