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

Sponsor
Ludwig-Maximilians - University of Munich (Other)
Overall Status
Unknown status
CT.gov ID
NCT01579253
Collaborator
(none)
10
1

Study Details

Study Description

Brief Summary

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.

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 .

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Untersuchungen Zur Verlaufskontrolle Bei Re-Bestrahlung Von Glioblastompatienten Mittels Kombinierter [18F]FET-PET-Kernspintomographie
Study Start Date :
Apr 1, 2012

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Munich, Dep. of Radiation Oncology Munich Bavaria Germany 81377

    Sponsors and Collaborators

    • Ludwig-Maximilians - University of Munich

    Investigators

    • Principal Investigator: Maximilian Niyazi, MD, MSc, Ludwig-Maximilians - University of Munich

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. med. Dipl.-Phys. Maximilian Niyazi, Principal Investigator, Ludwig-Maximilians - University of Munich
    ClinicalTrials.gov Identifier:
    NCT01579253
    Other Study ID Numbers:
    • 361-11
    First Posted:
    Apr 17, 2012
    Last Update Posted:
    Dec 18, 2012
    Last Verified:
    Dec 1, 2012

    Study Results

    No Results Posted as of Dec 18, 2012