Non-invasive Imaging With [18F]VM4-037

Phase 1

Withdrawn

• Conditions: Stage 4 Cancer

• Registration Number: NCT00935142
• Lead Sponsor: Maastricht Radiation Oncology

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) dose of \[18F\]VM4-037 via a bolus IV injection.

* Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of \[18F\]VM4-037 via a bolus IV injection

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-30
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Study Start: 2012-01
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Toxicity (CTCAE 3.0)	1 week

Secondary Outcome Measures

Name	Time	Method
Image Quality	1 week
Correlation with circulating biomarkers of hypoxia	1 week
Correlation with [18F]-FDG on PET scans	1 week