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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00935142
Recruitment Status : Withdrawn
First Posted : July 8, 2009
Last Update Posted : January 25, 2013
Maastricht University Medical Center
Information provided by (Responsible Party):
Maastricht Radiation Oncology

June 30, 2009
July 8, 2009
January 25, 2013
January 2012
November 2012   (Final data collection date for primary outcome measure)
Toxicity (CTCAE 3.0) [ Time Frame: 1 week ]
Same as current
Complete list of historical versions of study NCT00935142 on Archive Site
  • Image Quality [ Time Frame: 1 week ]
  • Correlation with circulating biomarkers of hypoxia [ Time Frame: 1 week ]
  • Correlation with [18F]-FDG on PET scans [ Time Frame: 1 week ]
Same as current
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Non-invasive Imaging With [18F]VM4-037
Non Invasive Imaging of [18F]VM4-037 With Positron-Emission-Tomography (PET): A Phase I Trial

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
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Stage 4 Cancer
Drug: [18F]VM4-037
Bolus IV injection of [18F]VM4-037
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Maastricht Radiation Oncology
Maastricht Radiation Oncology
Maastricht University Medical Center
Principal Investigator: Philippe Lambin, MD. PhD. Maastro Clinic, The Netherlands
Maastricht Radiation Oncology
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP