Study on Amino Acid Uptake in Brain Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University Hospital Muenster.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00204295
First received: September 13, 2005
Last updated: September 13, 2006
Last verified: September 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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
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: NCT00204295

Locations
Germany
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

No publications provided

ClinicalTrials.gov Identifier: NCT00204295     History of Changes
Other Study ID Numbers: FET-HT-MS
Study First Received: September 13, 2005
Last Updated: September 13, 2006
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

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

ClinicalTrials.gov processed this record on August 28, 2014