Glioblastoma MultiformeNCT01873469
Impact of [11C]-Methionine PET/MRI for Individual Tailoring Postoperative Radiochemotherapy for Glioblastoma Multiforme
An observational study of Glioblastoma Multiforme, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Local recurrence is a major problem of clinical treatment of glioblastoma multiforme (GBM). Today a very sensitive imaging method to detect glioblastoma is [11C]MET Positron emission tomography (PET), where in some patients also tumour manifestations can be detected that are not visible in MRI investigations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Radiochemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the diagnosis of glioblastoma multiforme
Who may be able to join
- histologically confirmed newly diagnosed glioblastoma multiforme
- macroscopic total tumour resection or biopsy
- indication for combined radiochemotherapy with temozolomide
- patients are allowed to take part in other clinical trials at the same time
- beginning of radiochemotherapy no later than 7 weeks after surgery
- Karnofsky Performance Score ≥ 60, ECOG ≤2
Show all 9Show fewer
- women with childbearing potential, (and men) adequate contraception
- ability of subject to understand character and individual consequences of the clinical trial
- written informed consent
Who cannot join
- previous radiotherapy of the brain or chemotherapy with TMZ other than during the radiochemotherapy
- time interval of > 7 weeks after surgery and beginning of radiochemotherapy
- patients who are not suitable for radiochemotherapy
- known other malignant disease that impacts prognosis of the patient and/or is likely to require treatment interfering with study therapy
- pregnant or lactating women
- patients with non-MRI compatible metal implants, pacemaker or non-MRI compatible external automatic defibrillators, insulin pumps, neurostimulators, cochlear implants
- Claustrophobic patients
- refusal of the patients to take part in the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Oncology; and DKTK partner site Dresden
Dresden, Saxony, 01307
About this study
Official title: Observational Study of Impact of [11C]-Methionine PET/MRI as a Tool for Individual Tailoring Postoperative Radiochemotherapy for Patients With Glioblastoma Multiforme
Local recurrence is a major problem of clinical treatment of glioblastoma multiforme (GBM). Today a very sensitive imaging method to detect glioblastoma is [11C]MET Positron emission tomography (PET), where in some patients also tumour manifestations can be detected that are not visible in MRI investigations.
The aim of the study is to investigate the association of high [11C]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with glioblastoma multiforme. Also site of recurrence will be correlated with the [11C]MET imaging before and early during radiochemotherapy. All imaging information will be included in treatment planning or treatment decisions.
The study provides a basis for later radiation dose escalation trials on the base of [11C]MET imaging.
Read the detailed description
The current study aims to investigate the association of high [11C]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with glioblastoma multiforme (GBM).
[11C]MET-PET is expected to provide diagnostic (quantitative and spatial information) as well as prognostic information, to monitor treatment, to help stratification of patients for radiotherapeutic interventions such as dose-painting in order to optimize clinical applications and potentially improve the treatment outcome.
This study aims to provide the basis (e.g. optimal threshold value, sensitivity, specificity of MET uptake) for later intervention trials for treatment intensification, e.g. proton boost irradiation based on specific biomarkers.
The trial is a one-arm single-center, non-randomized observational (biomarker) study. After resection or biopsy, patients with newly diagnosed glioblastoma multiforme will receive a [11C]MET-PET/MRI scan before start of concurrent radiochemotherapy (~1-4 weeks after surgery). A fusion with the planning CT for irradiation treatment planning will be performed. Postoperative radiotherapy will be applied in daily fractions of 2 Gy given 5 days per week for 6 weeks, for a total dose of 60 Gy (50 Gy and a boost of 10 Gy), with concomitant administration of daily Temozolomide (75 mg/m2 p.o.) from the 1st day to the last day of radiotherapy. Follow up with [11C]MET-PET/MRI will be performed every 3 months until recurrence or until death of the patient.
The uptake of [11C]MET-PET (as standard uptake value - SUV) in tumour and in normal contralateral grey matter before start of concurrent radiochemotherapy will be determined. For each tumour, the ratio between tracer uptake in the tumor and contralateral gray matter will be calculated (lesion-to-gray matter ratio [l/g]).
Primary end point will be time to recurrence (TTR) as function of [11C]MET uptake before chemoradiotherapy. Secondary endpoints will be overall survival; toxicity; C-Index/ROC curve (sensitivity, specificity, optimal threshold for normal/tumour tissue index), necrosis rate; site of recurrence.
The primary analysis will use the Cox proportional hazard model to establish the linear association between [11C]-MET and time-to-recurrence using a one-sided alpha = 0.1.
Parallel translational studies with orthotopic GBM xenografts (generated from the patients material in the trial) in nude mice will be performed in our laboratory to evaluate [11C]MET-PET as a tool for tailoring high precision radiotherapy. Histological, biological and genetic studies are planned to validate the imaging finding and to explore the underlying mechanisms.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Radiochemotherapy
- Keywords
- glioblastoma multiforme, radiotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiochemotherapyRadiation
postoperative radiochemotherapy 60 Gy/ Temozolomide
| Study group | Role | What they receive |
|---|---|---|
| Radiochemotherapy | glioblastoma patients with indication to radiochemotherapy Receives: Radiation: Radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence as function of [11C]MET uptake before postoperative radiochemotherapy
Measured: participants will be followed until tumour recurrence, an expected average of 7 months
Secondary outcomes (1)
overall survival
Measured: expected average 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mechthild Krause, Technische Universität Dresden
- Investigators
- Mechthild Krause, MD, Study chair, Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873469
- Sponsor's protocol ID
- STR-PETra-2013
- Status last verified
- Feb 2019
- First submitted
- 4 Jun 2013
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Impact of [11C]-Methionine PET/MRI as a Tool for Individual Tailoring Postoperative Radiochemotherapy for Patients With Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01873469
- Acronym / sponsor ID
- STR-PETra-2013
- Conditions
- Glioblastoma Multiforme
- Keywords
- glioblastoma multiforme, radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 10 Jun 2013 (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.
Local recurrence is a major problem of clinical treatment of glioblastoma multiforme (GBM). Today a very sensitive imaging method to detect glioblastoma is [11C]MET Positron emission tomography (PET), where in some patients also tumour manifestations can be detected that are not visible in MRI investigations.
The aim of the study is to investigate the association of high [11C]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with glioblastoma multiforme. Also site of recurrence will be correlated with the [11C]MET imaging before and early during radiochemotherapy. All imaging information will be included in treatment planning or treatment decisions.
The study provides a basis for later radiation dose escalation trials on the base of [11C]MET imaging.
Detailed description
The current study aims to investigate the association of high [11C]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with glioblastoma multiforme (GBM).
[11C]MET-PET is expected to provide diagnostic (quantitative and spatial information) as well as prognostic information, to monitor treatment, to help stratification of patients for radiotherapeutic interventions such as dose-painting in order to optimize clinical applications and potentially improve the treatment outcome.
This study aims to provide the basis (e.g. optimal threshold value, sensitivity, specificity of MET uptake) for later intervention trials for treatment intensification, e.g. proton boost irradiation based on specific biomarkers.
The trial is a one-arm single-center, non-randomized observational (biomarker) study. After resection or biopsy, patients with newly diagnosed glioblastoma multiforme will receive a [11C]MET-PET/MRI scan before start of concurrent radiochemotherapy (~1-4 weeks after surgery). A fusion with the planning CT for irradiation treatment planning will be performed. Postoperative radiotherapy will be applied in daily fractions of 2 Gy given 5 days per week for 6 weeks, for a total dose of 60 Gy (50 Gy and a boost of 10 Gy), with concomitant administration of daily Temozolomide (75 mg/m2 p.o.) from the 1st day to the last day of radiotherapy. Follow up with [11C]MET-PET/MRI will be performed every 3 months until recurrence or until death of the patient.
The uptake of [11C]MET-PET (as standard uptake value - SUV) in tumour and in normal contralateral grey matter before start of concurrent radiochemotherapy will be determined. For each tumour, the ratio between tracer uptake in the tumor and contralateral gray matter will be calculated (lesion-to-gray matter ratio [l/g]).
Primary end point will be time to recurrence (TTR) as function of [11C]MET uptake before chemoradiotherapy. Secondary endpoints will be overall survival; toxicity; C-Index/ROC curve (sensitivity, specificity, optimal threshold for normal/tumour tissue index), necrosis rate; site of recurrence.
The primary analysis will use the Cox proportional hazard model to establish the linear association between [11C]-MET and time-to-recurrence using a one-sided alpha = 0.1.
Parallel translational studies with orthotopic GBM xenografts (generated from the patients material in the trial) in nude mice will be performed in our laboratory to evaluate [11C]MET-PET as a tool for tailoring high precision radiotherapy. Histological, biological and genetic studies are planned to validate the imaging finding and to explore the underlying mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiochemotherapy | – | Radiation: Radiochemotherapyglioblastoma patients with indication to radiochemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis of glioblastoma multiforme
Key inclusion criteria (9 listed)
- histologically confirmed newly diagnosed glioblastoma multiforme
- macroscopic total tumour resection or biopsy
- indication for combined radiochemotherapy with temozolomide
- patients are allowed to take part in other clinical trials at the same time
- beginning of radiochemotherapy no later than 7 weeks after surgery
Key exclusion criteria (8 listed)
- previous radiotherapy of the brain or chemotherapy with TMZ other than during the radiochemotherapy
- time interval of > 7 weeks after surgery and beginning of radiochemotherapy
- patients who are not suitable for radiochemotherapy
- known other malignant disease that impacts prognosis of the patient and/or is likely to require treatment interfering with study therapy
- pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiochemotherapypostoperative radiochemotherapy 60 Gy/ Temozolomide | Radiation | Radiochemotherapy |
Primary outcome
Time to recurrence as function of [11C]MET uptake before postoperative radiochemotherapy
Time frame: participants will be followed until tumour recurrence, an expected average of 7 months
1 secondary outcome
overall survival
Time frame: expected average 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Mechthild Krause, MD study chair
Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden
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 Multiforme, run by Technische Universität Dresden 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 18 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recurrence as function of [11C]MET uptake before postoperative radiochemotherapy (time frame: participants will be followed until tumour recurrence, an expected average of 7 months). It is what the study was designed to measure, not a finding.
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 Feb 2019.