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This study has been withdrawn prior to enrollment.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Withdrawn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
Maastricht Radiation Oncology
January 2013

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