Study on Amino Acid Uptake in Brain Tumors
Recruitment status was Active, not recruiting
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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) |
- Histological samples where available
- CD98 staining where available
- Clinical follow-up for at least one year
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2004 |
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 |
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| Germany | |
| Department of Nuclear Medicine, University Hospital Muenster | |
| Muenster, NRW, Germany, D-48149 | |
| 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 May 23, 2013