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Study on Amino Acid Uptake in Brain Tumors

Primary Purpose

Brain Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Neoplasms focused on measuring Brain neoplasms, Positron-Emission Tomography, Amino Acids, Magnetic Resonance Imaging

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Nuclear Medicine, University Hospital Muenster

Outcomes

Primary Outcome Measures

Histological samples where available
CD98 staining where available

Secondary Outcome Measures

Clinical follow-up for at least one year

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2006
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT00204295
Brief Title
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

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Muenster

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
Keywords
Brain neoplasms, Positron-Emission Tomography, Amino Acids, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET
Primary Outcome Measure Information:
Title
Histological samples where available
Title
CD98 staining where available
Secondary Outcome Measure Information:
Title
Clinical follow-up for at least one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Weckesser, MD
Organizational Affiliation
Department of Nuclear Medicine, University Hospital Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nuclear Medicine, University Hospital Muenster
City
Muenster
State/Province
NRW
ZIP/Postal Code
D-48149
Country
Germany

12. IPD Sharing Statement

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Study on Amino Acid Uptake in Brain Tumors

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