CClinicalTrials.gg
Status unknownNCT01579253Updated Dec 18, 2012

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

An observational study in Glioblastoma, Nervous System Neoplasms and Central Nervous System Neoplasms, sponsored by Ludwig-Maximilians - University of Munich. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-12-18.

Sponsored by Ludwig-Maximilians - University of Munich · Observational

The sponsor has not verified this record recently (last verified Dec 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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 .

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Conditions studied

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

Keywords

  • Recurrent glioblastoma
  • Radiotherapy
  • PET-MRI
  • FET-PET
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In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 10 is below the median of 205 across 1,680 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • not willing or able to give free informed consent
  • pregnancy
  • claustrophobia
  • metallic objects or implanted medical devices in the body
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
06

Study locations

1 of 1 sites recruiting
  • University of Munich, Dep. of Radiation Oncology
    Munich, Bavaria 81377, Germany
    • Maximilian Niyazi, MD, MSc · Principal investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01579253
Lead sponsor
Ludwig-Maximilians - University of Munich
Responsible party
Dr. med. Dipl.-Phys. Maximilian Niyazi (Principal Investigator, Ludwig-Maximilians - University of Munich) — Principal investigator
First posted
Apr 17, 2012
Start date
Apr 2012
Last update
Dec 18, 2012

Study contacts

Maximilian Niyazi, MD, MSc
Contact
Maximilian.Niyazi@med.uni-muenchen.de
00498970953770
Maximilian Niyazi, MD, MSc
principal investigator · Ludwig-Maximilians - University of Munich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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