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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

NCT ID: NCT01579253

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Brief Summary

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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

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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 .

Conditions

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

Keywords

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Recurrent glioblastoma Radiotherapy PET-MRI FET-PET

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Dipl.-Phys. Maximilian Niyazi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maximilian Niyazi, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

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University of Munich, Dep. of Radiation Oncology

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Maximilian Niyazi, MD, MSc

Role: CONTACT

Phone: 00498970953770

Email: [email protected]

Other Identifiers

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361-11

Identifier Type: -

Identifier Source: org_study_id