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Study on Amino Acid Uptake in Brain Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: University Hospital Muenster
Information provided by: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00204295
  Purpose

The purpose of this study is to determine the uptake of the amino acid O-(2-[F-18]Fluorethyl)-L-tyrosin (FET) in human brain tumors using positron emission tomography. A comparison to MRI and histopathological samples is used.


Condition Intervention Phase
Brain Neoplasms
Drug: O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET
Phase II

MedlinePlus related topics:   Brain Cancer    Cancer    Childhood Brain Tumors   

ChemIDplus related topics:   Amino acids, branched-chain   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase 2 Study on Brain Tumor Uptake of the Amino Acid O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET)

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Histological samples where available
  • CD98 staining where available

Secondary Outcome Measures:
  • Clinical follow-up for at least one year

Estimated Enrollment:   60
Study Start Date:   January 2004

Detailed Description:

Radioactively labelled amino acids have been used for years to delineate primary brain tumors and for the early detection of tumor recurrence. Positron emission tomography studies indicate that the extent of amino acid uptake correlates to the true histological extent of gliomas. Recently a fluorine-18 labelled amino acid has been introduced (O-(2-[F-18]Fluorethyl)-L-tyrosin (FET)), which is suitable for routine use in brain tumor patients. There is evidence that this amino acid is transported into brain and brain tumors by the amino acid transport of the L-type. The cDNA of this L-transporter has recently been cloned and has been shown to be identical to the light chain of the 4F2-antigen (CD98), which has previously been described as marker of cell growth and proliferation.

The heavy chain of this heterodimer is known to modulate integrins which are thought to play a fundamental role in glioma invasion.

Besides the evaluation of the diagnostic capability of FET in brain tumors, a comparison of FET uptake in vivo and CD98 expression ex-vivo is performed with tissue slices as available after routine surgery in glioma patients.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients with suspected primary brain tumors
  • CT or MRI showing lesion of >= 2,5 cm
  • Any age; parents informed consent in children available
  • Karnofsky-Index >= 20 %
  • Referral by Depts. of Neurology, Neuro-Oncology, Neurosurgery, or Pediatric Neurology at the UKM
  • Biopsy and/or surgery planned
  • Patient is able to lie during the PET scan for 50 minutes without moving • Patient must be able to give informed consent; signature must be present before the PET scan

Exclusion Criteria:

  • Pregnancy or breast feeing
  • Patients, who by psychiatric disease are not able to give informed consent
  • Complete renal failure
  • Inclusion to other studies according to § 23 of the German radiation protection law
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204295

Locations
Germany, NRW
Department of Nuclear Medicine, University Hospital Muenster    
      Muenster, NRW, Germany, D-48149

Sponsors and Collaborators
University Hospital Muenster

Investigators
Principal Investigator:     Matthias Weckesser, MD     Department of Nuclear Medicine, University Hospital Muenster    
  More Information


Study ID Numbers:   FET-HT-MS
First Received:   September 13, 2005
Last Updated:   September 13, 2006
ClinicalTrials.gov Identifier:   NCT00204295
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices;   Germany: Federal Office for Radiation Protection (BfS)

Keywords provided by University Hospital Muenster:
Brain neoplasms  
Positron-Emission Tomography  
Amino Acids  
Magnetic Resonance Imaging  

Study placed in the following topic categories:
Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2008




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