NCT01089868

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

4.4 years

First QC Date

March 17, 2010

Last Update Submit

August 5, 2012

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma multiformeMicrosurgeryStereotactic biopsyRadiochemotherapyTemodarFET PETMolecular imaging

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    46 months

Secondary Outcomes (1)

  • Progression Free Survival

    46 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been referred to a neurosurgical department for diagnosis and therapy of a brain tumor

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Stereotactic Neurosurgery

Freiburg im Breisgau, Baden-Wurttemberg, 79095, Germany

Location

University Hospital Munich, Department of Neurosurgery

Munich, Bavaria, 81377, Germany

Location

University Hospital Bonn, Department of Neurosurgery

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Related Publications (1)

  • Ingrisch M, Schneider MJ, Norenberg D, Negrao de Figueiredo G, Maier-Hein K, Suchorska B, Schuller U, Albert N, Bruckmann H, Reiser M, Tonn JC, Ertl-Wagner B. Radiomic Analysis Reveals Prognostic Information in T1-Weighted Baseline Magnetic Resonance Imaging in Patients With Glioblastoma. Invest Radiol. 2017 Jun;52(6):360-366. doi: 10.1097/RLI.0000000000000349.

    PMID: 28079702DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA and RNA samples for MGMT methylation and LOH 1p and 19q status analysis

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Joerg C. Tonn, Prof. Dr.

    Department of Neurosurgery, LMU, Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 17, 2010

First Posted

March 19, 2010

Study Start

January 1, 2007

Primary Completion

June 1, 2011

Study Completion

July 1, 2012

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

DE(3)