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Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients

Study Purpose

The aim of this study is to establish FET-PET as an additional therapy assessment parameter in patients diagnosed with a glioblastoma multiforme receiving radiochemotherapy and adjuvant chemotherapy after previous resection or biopsy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - neuroradiologically suspected Glioblastoma multiforme.
  • - histological verification will be obtained either by microsurgery or by stereotactic biopsy.
The neuropathological diagnosis will be verified by a reference neuropathologist.
  • - patients will undergo radiochemotherapy subsequent to surgical procedure.
  • - patients older than 18 years.
  • - Karnofsky Performance Score >=70.
  • - pregnant or nursing female patients will not be included in this study.
  • - safe contraceptive methods during the radiochemotherapy and chemotherapy.

Exclusion Criteria:

  • - patients in whom informed consent cannot be obtained due to organic brain syndrome or insufficient language skills.
  • - patients who cannot lie quiet for a time period of app.
two hours during the FET-PEt scan.
  • - medical history of a metastatic brain disease.
- patients in whom an MRI scan cannot be performed due to claustrophobia metallic protheses or pacemakers etc.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01089868
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Ludwig-Maximilians - University of Munich
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Joerg C. Tonn, Prof. Dr.
Principal Investigator Affiliation Department of Neurosurgery, LMU, Munich
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Arms & Interventions

Arms

: Group A

Patients who suffer from a suspected GBM and will undergo a microsurgical procedure for diagnosis verification. MRI and Positron Emission Tomography (PET) scans are scheduled prior to microsurgery, post microsurgery and after having completed radiochemotherapy and an additional scan after TMZ chemotherapy.

: Group B

Patients enrolled in Group B suffer from a suspected GBM which cannot be accessed microsurgically either due to a an eloquent location of the tumor, or patient's refusal to undergo surgery. In these patients, diagnosis will be obtained by means of stereotactic surgery. After an initial PET and MRI scan prior to biopsy, patients will be monitored by post radiochemotherapy as well as post 3-months chemotherapy MRI/PET scans.

Interventions

Contact a Trial Team

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International Sites

Department of Stereotactic Neurosurgery, Freiburg, Baden Wuertemberg, Germany

Status

Address

Department of Stereotactic Neurosurgery

Freiburg, Baden Wuertemberg, 79095

Munich, Bavaria, Germany

Status

Address

University Hospital Munich, Department of Neurosurgery

Munich, Bavaria, 81377

Bonn, North Rhine-Westphalia, Germany

Status

Address

University Hospital Bonn, Department of Neurosurgery

Bonn, North Rhine-Westphalia, 53127

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