NCT00204295

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 14, 2006

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

September 13, 2006

Conditions

Brain Neoplasms

Keywords

Brain neoplasmsPositron-Emission TomographyAmino AcidsMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

  • Histological samples where available

  • CD98 staining where available

Secondary Outcomes (1)

  • Clinical follow-up for at least one year

Interventions

O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PETDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or breast feeing
  • Patients, who by psychiatric disease are not able to give informed consent
  • Complete renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, University Hospital Muenster

Münster, North Rhine-Westphalia, D-48149, Germany

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Matthias Weckesser, MD

    Department of Nuclear Medicine, University Hospital Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2004

Last Updated

September 14, 2006

Record last verified: 2006-09

Locations

DE(1)