- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00204295
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)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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NRW
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Muenster, NRW, Germany, D-48149
- Department of Nuclear Medicine, University Hospital Muenster
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Histological samples where available
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CD98 staining where available
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Secondary Outcome Measures
Outcome Measure |
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Clinical follow-up for at least one year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthias Weckesser, MD, Department of Nuclear Medicine, University Hospital Muenster
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FET-HT-MS
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