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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This study has been withdrawn prior to enrollment.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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, The Netherlands
  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 November 20, 2014