Cerebral Astrocytoma, High GradeNCT00643591
Positron Emission Tomography-Computed Tomography (PET-CT) High-grade Glioma
An observational study of Cerebral Astrocytoma, High Grade, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
The objectives of the trial are: To determine the localisation within the primary tumor of the therapy resistant cells, before and during radiotherapy to determine a possible accurate boost volume. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cerebral Astrocytoma, High Grade
- What is being tested?
- imaging (dynamic PET-CT scan)
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2008to Jun 2010
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with radical radiotherapy for a high grade glioma.
Who may be able to join
- Histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma, gliosarcoma) at primary diagnosis;
- WhO PFS <= 2
- Tumours which do enhance on pre-operative imaging.
- Post-operative enough visible residual tumour on PET or status after biopsy only
- Age >18 years
- Availability of deep fresh frozen tissue for molecular biologic evaluation - if possible
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- Patient able to tolerate full course of conventional RT and follow serial scanning
- No previous radiotherapy to the head and neck and brain area.
- Prior neurosurgery within 6 weeks of treatment
- No previous chemotherapy before treatment of the glioma. Standard radiochemotherapy with temozolomide is not excluded
- No prior or concurrent medical condition which would make treatment difficult to complete. Medication with steroids is allowed.
- No incapacitated patients.
Who cannot join
- Not histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma, gliosarcoma) at primary diagnosis;
- WhO PFS > 2
- No tumours which do enhance on pre-operative imaging.
- Post-operative not enough visible residual tumor on PET or status after biopsy only
- Age <18 years
- No availability of deep fresh frozen tissue for molecular biologic evaluation
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- Patient not able to tolerate full course of conventional RT and follow serial scanning
- Previous radiotherapy to the head and neck and brain area.
- Prior neurosurgery not within 6 weeks of treatment
- Previous chemotherapy before treatment of the glioma.
- Prior or concurrent medical condition which would make treatment difficult to complete.
- Incapacitated patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Determination of Therapy Resistant Areas Within the Tumor in Patients With High-grade Glioma by Repeated 18F-FDG-PET-CT Scans
The objectives of the trial are:
- To determine the localisation within the primary tumor of the therapy resistant cells, before and during radiotherapy to determine a possible accurate boost volume.
- To determine changes during treatment intra- and extratumoral within the irradiated area.(Intratumoral: change of up-take - decrease, increase, change of localization/ Extratumoral: effects of temporal changes in up-take - e.g. due to oedema).
Read the detailed description
Patients harboring a primary intracerebral high grade tumor (WHO III- IV) have a median survival of six to 12 months. Combined chemoradiotherapy with temozolomide is now the standard of care since results of the joint EORTC-NCIC phase III study randomizing between radiotherapy alone and combined radiochemotherapy with temozolomide showed a significant improvement in 2-years survival from 8% to 24% for the combined treatment arm (Stupp 2005).
A differentiation between possible responders and non-responders before the start of irradiation may eventual be possible by the use of 18F-FDG PET-CT. Preliminary own results have shown that a higher metabolic activity in glioblastoma as measured on a simulation 18F-FDG PET-CT scan can be a prognosticator for shortened survival (Baumert, 2006).
Our preliminary data show that a high uptake of 18F-FDG on a PET-CT scan before radiotherapy in glioblastoma could be a marker for reduced survival.
Popperl et al showed that dual phase FDG PET imaging is superior in differentiating low-grade from high-grade recurrent astrocytomas (Popperl, 2006). Visual analysis of delineation of glioma showed that the delayed images (imaged first 0-90 min and once or twice later at 180-480 min after injection) better distinguished the high uptake in tumors relative to uptake in gray matter. SUV comparisons also showed greater uptake in the tumors than in gray matter, brain, or white matter at the delayed times (Spence et al).
These findings support the view that by using FDG-PET scans we could image active areas within the tumor. Indeed, in vivo, a cancer is made up by different types of cells, including hypoxic cells, cells that proliferate more fast, as well as by non-malignant tissues, including inflammatory cells and vasculature.
Intra-tumor heterogeneity in malignant glioma is often observed and can be visualised also by current PET-CT techniques.
The dynamics of the tracer uptake in the different tumor sub-volumes may give important information about the biological characteristics as well. Indeed, the dynamics of FDG uptake per cell are dependent on the blood flow, the uptake in the cell and the phosphorylation. All these of these steps give information on the biology of the cancer in that particular area of the tumor.
- Conditions
- Cerebral Astrocytoma, High Grade
- Being tested
- imaging (dynamic PET-CT scan)
- Keywords
- high grade glioma, FDG-PET-CT, blood proteins, prognosis
- Medical subject headings
- Astrocytoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaging (dynamic PET-CT scan)Other
dynamic PET-CT scan
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients with a primary glioblastoma Receives: Other: imaging (dynamic PET-CT scan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the localisation within the primary tumour of the therapy resistant cells, before and during radiotherapy to determine the accurate boost volume. To determine changes during treatment intra- and extratumoral within the irradiated area.
Measured: after acquisition of all planned PET CTs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2010
Why it stopped: Patient compliance was low.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Astrocytoma, High GradeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Sponsor
- Investigators
- Brigitta Baumert, MD PhD, Principal investigator, Maastricht Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643591
- Sponsor's protocol ID
- MAASTRO 07-12-12/09
- Other IDs
- EudraCT Number 2007-005530-36
- Status last verified
- Apr 2015
- First submitted
- 20 Mar 2008
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Determination of Therapy Resistant Areas Within the Tumor in Patients With High-grade Glioma by Repeated 18F-FDG-PET-CT Scans
- ClinicalTrials.gov ID
- NCT00643591
- Acronym / sponsor ID
- MAASTRO 07-12-12/09
- Conditions
- Cerebral Astrocytoma, High Grade
- Keywords
- high grade glioma, FDG-PET-CT, blood proteins, prognosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patient compliance was low.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Mar 2008 (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.
The objectives of the trial are:
- To determine the localisation within the primary tumor of the therapy resistant cells, before and during radiotherapy to determine a possible accurate boost volume.
- To determine changes during treatment intra- and extratumoral within the irradiated area.(Intratumoral: change of up-take - decrease, increase, change of localization/ Extratumoral: effects of temporal changes in up-take - e.g. due to oedema).
Detailed description
Patients harboring a primary intracerebral high grade tumor (WHO III- IV) have a median survival of six to 12 months. Combined chemoradiotherapy with temozolomide is now the standard of care since results of the joint EORTC-NCIC phase III study randomizing between radiotherapy alone and combined radiochemotherapy with temozolomide showed a significant improvement in 2-years survival from 8% to 24% for the combined treatment arm (Stupp 2005).
A differentiation between possible responders and non-responders before the start of irradiation may eventual be possible by the use of 18F-FDG PET-CT. Preliminary own results have shown that a higher metabolic activity in glioblastoma as measured on a simulation 18F-FDG PET-CT scan can be a prognosticator for shortened survival (Baumert, 2006).
Our preliminary data show that a high uptake of 18F-FDG on a PET-CT scan before radiotherapy in glioblastoma could be a marker for reduced survival.
Popperl et al showed that dual phase FDG PET imaging is superior in differentiating low-grade from high-grade recurrent astrocytomas (Popperl, 2006). Visual analysis of delineation of glioma showed that the delayed images (imaged first 0-90 min and once or twice later at 180-480 min after injection) better distinguished the high uptake in tumors relative to uptake in gray matter. SUV comparisons also showed greater uptake in the tumors than in gray matter, brain, or white matter at the delayed times (Spence et al).
These findings support the view that by using FDG-PET scans we could image active areas within the tumor. Indeed, in vivo, a cancer is made up by different types of cells, including hypoxic cells, cells that proliferate more fast, as well as by non-malignant tissues, including inflammatory cells and vasculature.
Intra-tumor heterogeneity in malignant glioma is often observed and can be visualised also by current PET-CT techniques.
The dynamics of the tracer uptake in the different tumor sub-volumes may give important information about the biological characteristics as well. Indeed, the dynamics of FDG uptake per cell are dependent on the blood flow, the uptake in the cell and the phosphorylation. All these of these steps give information on the biology of the cancer in that particular area of the tumor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: imaging (dynamic PET-CT scan)Patients with a primary glioblastoma |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with radical radiotherapy for a high grade glioma.
Key inclusion criteria (12 listed)
- Histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma, gliosarcoma) at primary diagnosis;
- WhO PFS <= 2
- Tumours which do enhance on pre-operative imaging.
- Post-operative enough visible residual tumour on PET or status after biopsy only
- Age >18 years
Key exclusion criteria (12 listed)
- Not histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma, gliosarcoma) at primary diagnosis;
- WhO PFS > 2
- No tumours which do enhance on pre-operative imaging.
- Post-operative not enough visible residual tumor on PET or status after biopsy only
- Age <18 years
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 |
|---|---|---|
| imaging (dynamic PET-CT scan)dynamic PET-CT scan | Other | Observational |
Primary outcome
To determine the localisation within the primary tumour of the therapy resistant cells, before and during radiotherapy to determine the accurate boost volume. To determine changes during treatment intra- and extratumoral within the irradiated area.
Time frame: after acquisition of all planned PET CTs
Results and safety
The study was stopped early (reason given: Patient compliance was low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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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.
Brigitta Baumert, MD PhD principal investigator
Maastricht Radiation Oncology
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 Cerebral Astrocytoma, High Grade, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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 12 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Apr 2015. 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 Netherlands. 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 was stopped early (reason given: Patient compliance was low.). Results are not available in the source record.
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?
To determine the localisation within the primary tumour of the therapy resistant cells, before and during radiotherapy to determine the accurate boost volume. To determine changes during treatment intra- and extratumoral within the irradiated area. (time frame: after acquisition of all planned PET CTs). 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 10 Apr 2015.