- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01579253
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
Untersuchungen Zur Verlaufskontrolle Bei Re-Bestrahlung Von Glioblastompatienten Mittels Kombinierter [18F]FET-PET-Kernspintomographie
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Maximilian Niyazi, MD, MSc
- Phone Number: 00498970953770
- Email: Maximilian.Niyazi@med.uni-muenchen.de
Study Locations
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Bavaria
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Munich, Bavaria, Germany, 81377
- Recruiting
- University of Munich, Dep. of Radiation Oncology
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Principal Investigator:
- Maximilian Niyazi, MD, MSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Maximilian Niyazi, MD, MSc, Ludwig-Maximilians - University of Munich
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Germ Cell and Embryonal
- Neoplasms
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Astrocytoma
- Neoplasms by Histologic Type
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
- Neoplasms, Neuroepithelial
- Neoplasms, Nerve Tissue
Other Study ID Numbers
- 361-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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