GlioblastomaNCT01579253
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 of Glioblastoma and Nervous System Neoplasms, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma, Nervous System Neoplasms, Central Nervous System Neoplasms
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent glioblastoma who are planned to receive a re-irradiation
Who may be able to join
- 18 - 75 years old
- histologically or magnetic resonance imaging proven recurrent glioblastoma
- re-irradiation possible
- willing and able to give free informed consent
Who cannot join
- not willing or able to give free informed consent
- pregnancy
- claustrophobia
- metallic objects or implanted medical devices in the body
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Munich, Dep. of Radiation Oncology
Munich, Bavaria, 81377
Maximilian Niyazi, MD, MSc
About this study
Official title: Untersuchungen Zur Verlaufskontrolle Bei Re-Bestrahlung Von Glioblastompatienten Mittels Kombinierter [18F]FET-PET-Kernspintomographie
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 .
- Conditions
- Glioblastoma, Nervous System Neoplasms, Central Nervous System Neoplasms, Astrocytoma, Glioma, Neoplasms, Neuroepithelial
- Keywords
- Recurrent glioblastoma, Radiotherapy, PET-MRI, FET-PET
- Medical subject headings
- Glioblastoma, Nervous System Neoplasms, Central Nervous System Neoplasms, Astrocytoma, Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms by Histologic Type
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Dipl.-Phys. Maximilian Niyazi, Ludwig-Maximilians - University of Munich
- Investigators
- Maximilian Niyazi, MD, MSc, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579253
- Sponsor's protocol ID
- 361-11
- Status last verified
- Dec 2012
- First submitted
- 15 Apr 2012
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Untersuchungen Zur Verlaufskontrolle Bei Re-Bestrahlung Von Glioblastompatienten Mittels Kombinierter [18F]FET-PET-Kernspintomographie
- ClinicalTrials.gov ID
- NCT01579253
- Acronym / sponsor ID
- 361-11
- Conditions
- Glioblastoma, Nervous System Neoplasms, Central Nervous System Neoplasms, Astrocytoma, Glioma, Neoplasms, Neuroepithelial
- Keywords
- Recurrent glioblastoma, Radiotherapy, PET-MRI, FET-PET
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Apr 2012
- First posted
- 17 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent glioblastoma who are planned to receive a re-irradiation
Key inclusion criteria (4 listed)
- 18 - 75 years old
- histologically or magnetic resonance imaging proven recurrent glioblastoma
- re-irradiation possible
- willing and able to give free informed consent
Key exclusion criteria (4 listed)
- not willing or able to give free informed consent
- pregnancy
- claustrophobia
- metallic objects or implanted medical devices in the body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximilian Niyazi, MD, MSc principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma and Nervous System Neoplasms, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maximilian Niyazi, MD, MSc (00498970953770, Maximilian.Niyazi@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.