Clinical trial NCT00204295: Study on Amino Acid Uptake in Brain Tumors
Official title: Phase 2 Study on Brain Tumor Uptake of the Amino Acid O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain Neoplasms
Keywords: Brain neoplasms
Positron-Emission Tomography
Amino Acids
Magnetic Resonance Imaging
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Histological samples where available
measure: CD98 staining where available
Secondary outcomes:
measure: Clinical follow-up for at least one year
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Nuclear Medicine, University Hospital Muenster
state: NRW
Study officials:
affiliation: Department of Nuclear Medicine, University Hospital Muenster
name: Matthias Weckesser, MD
role: PRINCIPAL_INVESTIGATOR
References: