Study on Amino Acid Uptake in Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00204295
Recruitment Status : Unknown
Verified September 2006 by University Hospital Muenster.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : September 14, 2006
Information provided by:
University Hospital Muenster

Brief Summary:
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 or disease Intervention/treatment Phase
Brain Neoplasms Drug: O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 2 Study on Brain Tumor Uptake of the Amino Acid O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET)
Study Start Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Primary Outcome Measures :
  1. Histological samples where available
  2. CD98 staining where available

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00204295

Department of Nuclear Medicine, University Hospital Muenster
Muenster, NRW, Germany, D-48149
Sponsors and Collaborators
University Hospital Muenster
Principal Investigator: Matthias Weckesser, MD Department of Nuclear Medicine, University Hospital Muenster Identifier: NCT00204295     History of Changes
Other Study ID Numbers: FET-HT-MS
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 14, 2006
Last Verified: September 2006

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

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