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

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ClinicalTrials.gov Identifier: NCT00935142
Recruitment Status : Withdrawn
First Posted : July 8, 2009
Last Update Posted : January 25, 2013
Sponsor:
Collaborator:
Maastricht University Medical Center
Information provided by (Responsible Party):
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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non Invasive Imaging of [18F]VM4-037 With Positron-Emission-Tomography (PET): A Phase I Trial
Study Start Date : January 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Intervention Details:
    Drug: [18F]VM4-037
    Bolus IV injection of [18F]VM4-037


Primary Outcome Measures :
  1. Toxicity (CTCAE 3.0) [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Image Quality [ Time Frame: 1 week ]
  2. Correlation with circulating biomarkers of hypoxia [ Time Frame: 1 week ]
  3. Correlation with [18F]-FDG on PET scans [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935142


Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University Medical Center
Investigators
Principal Investigator: Philippe Lambin, MD. PhD. Maastro Clinic, The Netherlands

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT00935142     History of Changes
Other Study ID Numbers: [18F]VM4-037
CaIX
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

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