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This study has been withdrawn prior to enrollment.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
  Purpose

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

Condition Intervention Phase
Stage 4 Cancer
Drug: [18F]VM4-037
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Non Invasive Imaging of [18F]VM4-037 With Positron-Emission-Tomography (PET): A Phase I Trial

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Toxicity (CTCAE 3.0) [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: [18F]VM4-037
    Bolus IV injection of [18F]VM4-037
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935142

Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University Medical Center
Investigators
Principal Investigator: Philippe Lambin, MD. PhD. MAASTRO Clinic
  More Information

No publications provided

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT00935142     History of Changes
Other Study ID Numbers: [18F]VM4-037, CaIX
Study First Received: June 30, 2009
Last Updated: January 24, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
stage IV cancer with no treatment options
non-curative

ClinicalTrials.gov processed this record on April 22, 2014