Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 13, 2005
September 13, 2006
January 2004
Not Provided
  • Histological samples where available
  • CD98 staining where available
Same as current
Complete list of historical versions of study NCT00204295 on ClinicalTrials.gov Archive Site
Clinical follow-up for at least one year
Same as current
Not Provided
Not Provided
 
Study on Amino Acid Uptake in Brain Tumors
Phase 2 Study on Brain Tumor Uptake of the Amino Acid O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Brain Neoplasms
Drug: O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Not Provided
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00204295
FET-HT-MS
Not Provided
Not Provided
University Hospital Muenster
Not Provided
Principal Investigator: Matthias Weckesser, MD Department of Nuclear Medicine, University Hospital Muenster
University Hospital Muenster
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP