Combined O-(2-[18F]Fluoroethyl)-L-tyrosine (FET) Positron Emission Tomography (PET) and Simultaneous Magnetic Resonance Imaging (MRI) Follow-up in Re-irradiated Recurrent Glioblastoma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Ludwig-Maximilians - University of Munich
Sponsor:
Information provided by (Responsible Party):
Dr. med. Dipl.-Phys. Maximilian Niyazi, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01579253
First received: April 15, 2012
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

Patients with recurrent glioblastoma who are planned to receive a second course of radiation are to be included into this monocentric cohort trial. Due to multiple pre-treatments simultaneous combined positron emission tomography (PET) with O-(2-[18F]fluoroethyl)-l-tyrosine (FET) as well as magnetic resonance imaging (MRI) is used for treatment planning and follow-up imaging as it allows for a better distinction between treatment-related changes and viable tumor tissue.


Condition
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Untersuchungen Zur Verlaufskontrolle Bei Re-Bestrahlung Von Glioblastompatienten Mittels Kombinierter [18F]FET-PET-Kernspintomographie

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Estimated Enrollment: 10
Study Start Date: April 2012
Detailed Description:

For glioblastoma (GBM) patients it has been proven that a [18F]FET-PET scan is very helpful especially in target volume definition and after the treatment, in turn, the combination of MRI and [18F]FET-PET is diagnostically most useful to distinguish between radiation necrosis and a real progressive disease.

The response to therapy is based on the newly formulated Revised Assessment in Neuro-Oncology (RANO) criteria. Kinetic and static [18F]FET-PET scans are useful to supplement this modality and its own prognostic value concerning relapsing patients will be examined.

The special feature of this study is the use of both modalities in parallel, allowing simultaneous acquisition of morphological changes, functional and molecular imaging.

Secondary methodological issues are dealt with, such as the relationship between contrast uptake, perfusion and [18F]FET uptake. In this regard, the hybrid imaging may serve for hypothesis generation, as in parallel in a unique way of contrast enhancement and tracer kinetics can be investigated (simultaneous contrast-enhanced analysis and tracer application).

In particular, FET kinetics are examined in more detail (for example, differences between increasing and decreasing kinetics) to find ways of how to use certain MRI sequences for better visualization of viable tumor tissue and vice versa .

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with recurrent glioblastoma who are planned to receive a re-irradiation

Criteria

Inclusion Criteria:

  • 18 - 75 years old
  • histologically or magnetic resonance imaging proven recurrent glioblastoma
  • re-irradiation possible
  • willing and able to give free informed consent

Exclusion Criteria:

  • not willing or able to give free informed consent
  • pregnancy
  • claustrophobia
  • metallic objects or implanted medical devices in the body
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579253

Contacts
Contact: Maximilian Niyazi, MD, MSc 00498970953770 Maximilian.Niyazi@med.uni-muenchen.de

Locations
Germany
University of Munich, Dep. of Radiation Oncology Recruiting
Munich, Bavaria, Germany, 81377
Principal Investigator: Maximilian Niyazi, MD, MSc         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Maximilian Niyazi, MD, MSc Ludwig-Maximilians - University of Munich
  More Information

No publications provided

Responsible Party: Dr. med. Dipl.-Phys. Maximilian Niyazi, Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01579253     History of Changes
Other Study ID Numbers: 361-11
Study First Received: April 15, 2012
Last Updated: December 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
Recurrent glioblastoma
Radiotherapy
PET-MRI
FET-PET

Additional relevant MeSH terms:
Astrocytoma
Neoplasms
Glioblastoma
Glioma
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014