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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Maastricht University Medical Center
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00935142
First received: June 30, 2009
Last updated: January 24, 2013
Last verified: January 2013

June 30, 2009
January 24, 2013
January 2012
November 2012   (final data collection date for primary outcome measure)
Toxicity (CTCAE 3.0) [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00935142 on ClinicalTrials.gov Archive Site
  • Image Quality [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Correlation with circulating biomarkers of hypoxia [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Correlation with [18F]-FDG on PET scans [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Stage 4 Cancer
Drug: [18F]VM4-037
Bolus IV injection of [18F]VM4-037
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00935142
[18F]VM4-037, CaIX
Yes
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