GlioblastomaNCT02585219
Pilot Viability of 11C-MET-PET as a Post-surgery Baseline Scan in High-grade Gliomas
An observational study of Glioblastoma, run by University Medical Center Groningen.
Trial summary
The tracer 11C-methionine (11 C-MET) is used as a specific cell proliferation tracer which shows metabolically active tumordeposities. A healthy brain barely takes up 11C-MET, causing the difference between the background and the tumor to be realively high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2017
- 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 suspicion of newly diagnosed high-grade glioma eligible for standard therapy (surgical resection followed by chemoradiotherapy). Patients with a second brain tumor, brain surgery earlier or prior radiotherapy to the brain are excluded. Patients with only a biopsy be excluded. The group will consist of 10 patients. This number may be adjusted for patients who are found to have a different diagnosis after histological examination or fall out. For a pilot feasibility study our experience that a number of 10 patients is sufficient for PET examination.
Who may be able to join
- Patients with suspicion of newly diagnosed high-grade glioma who qualify for the standard treatment. Written informed consent
Who cannot join
- Patients with recurrent high-grade glioma or other brain tumor as a secondary diagnosis are excluded.
- In addition, all patients who have had previous brain surgery or radiotherapy to the brain are also excluded.
- Patients with only a biopsy will be excluded. Patients under the age of 18 years will not be included.
- General exclusion criteria for MRI are exclusion criteria for participation in this study. The general MRI exclusion criteria are: not MRI compatible ferromagnetic material, pregnancy (or presumption thereof) and claustrophobia.
About this study
Official title: Pilot Feasibility of 11C-MET-PET as a Post-surgery Baseline Scan in the Follow-up of High-grade Gliomas for the Detection of Tumor Recurrence.
The tracer 11C-methionine (11 C-MET) is used as a specific cell proliferation tracer which shows metabolically active tumordeposities. A healthy brain barely takes up 11C-MET, causing the difference between the background and the tumor to be realively high. In addition, there is relatively little 11C-MET uptake in inflammatory processes. This makes 11C-MET a very suitable positron emission tomography (PET) tracer in order to differentiate between tumor progression and therapy changes. The latter is a major clinical problem for which further investigation is necessary.
In order to be able to make this differentiation, a direct post-operative baseline scan is required. With regard to the advanced MRI sequences, it is known that it is necessary to produce the post-operative baseline scan within 48 hours. After that timeframe, operation induced changes start to occur, such as granulation tissue. In that case the interpretation of the scan is no longer possible. Immediately postoperatively (<48 hours) 11C-MET has never been used before. Therefore, it is unknown whether 11C-MET provides a good baseline scan directly after surgery. This pilot will investigate the feasibility of this 11C-MET baseline scan and comparison the results with the advanced MRI sequences.
Read the detailed description
Conventional MRI, advanced MRI and 11C-MET-PET will be conducted on the same day. The advanced MRI will consist of diffusion weighted imaging (DWI), perfusion imaging by contrast technique (DSC) and spectroscopy (MRS). The post-operative MRI and PET scan will be produced within 48 hours after surgery (with the aim that operative effects are not visible on the baseline scan). This corresponds to the current practice of conventional MRI follow-up at the end of the radiotherapy.
The comparison with the pre-operative scan is to assess the viability of the post-operative scan. It will assessed whether the preoperative tumor uptake will disappear in accordance to the resection, as shown by the advanced MRI sequences. In addition, it will be assessed whether there are no interfering postoperative effects. The 11C-MET-PET scans will be interpreted in comparison with the quantitative results obtained with advanced MRI sequences (perfusion / diffusion / oxygenation / spectroscopy). If an immediate postoperative 11C-MET-PET proves to be feasible, than this will provide a basis for further research. This future research consist out of the differentiation between tumor progression and therapy change, one of the most urgent clinical dilemmas in neuro-oncology.
- Conditions
- Glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-grade Glioma Patients | Patients with suspicion of newly diagnosed high-grade glioma eligible for standard therapy (surgical resection followed by chemoradiotherapy). Patients with a second brain tumor, brain surgery earlier or prior radiotherapy to the brain are excluded. Patients with only a biopsy be excluded. The group will consist of 10 patients. This number may be adjusted for patients who are found to have a different diagnosis after histological examination or fall out. For a pilot feasibility study our experience that a number of 10 patients is sufficient for PET examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual comparison of pre- and post-surgery 11C-MET-PET
The 11C-MET-PET within 48 hours postoperatively will be assessed visually and quantitatively and compared with the preoperative 11C-MET-PET scan. The 11C-MET-PET data will also be checked by comparison with the results of the advanced MRI sequences. Specifically the comparison will include evaluation of surgical success (all former positive 11C-MET uptake removed) and evaluation of possible post-surgical effects on the second 11C-MET-PET.
Measured: 1 week between pre- and post-surgery 11C-MET-PET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJul 2017 (estimated)
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.
- More trials run by University Medical Center GroningenThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald W J van Rheenen, MD, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585219
- Sponsor's protocol ID
- NL50485.042.14
- Status last verified
- Oct 2015
- First submitted
- 21 Oct 2015
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility of 11C-MET-PET as a Post-surgery Baseline Scan in the Follow-up of High-grade Gliomas for the Detection of Tumor Recurrence.
- ClinicalTrials.gov ID
- NCT02585219
- Acronym / sponsor ID
- NL50485.042.14
- Conditions
- Glioblastoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 23 Oct 2015 (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 tracer 11C-methionine (11 C-MET) is used as a specific cell proliferation tracer which shows metabolically active tumordeposities. A healthy brain barely takes up 11C-MET, causing the difference between the background and the tumor to be realively high. In addition, there is relatively little 11C-MET uptake in inflammatory processes. This makes 11C-MET a very suitable positron emission tomography (PET) tracer in order to differentiate between tumor progression and therapy changes. The latter is a major clinical problem for which further investigation is necessary.
In order to be able to make this differentiation, a direct post-operative baseline scan is required. With regard to the advanced MRI sequences, it is known that it is necessary to produce the post-operative baseline scan within 48 hours. After that timeframe, operation induced changes start to occur, such as granulation tissue. In that case the interpretation of the scan is no longer possible. Immediately postoperatively (<48 hours) 11C-MET has never been used before. Therefore, it is unknown whether 11C-MET provides a good baseline scan directly after surgery. This pilot will investigate the feasibility of this 11C-MET baseline scan and comparison the results with the advanced MRI sequences.
Detailed description
Conventional MRI, advanced MRI and 11C-MET-PET will be conducted on the same day. The advanced MRI will consist of diffusion weighted imaging (DWI), perfusion imaging by contrast technique (DSC) and spectroscopy (MRS). The post-operative MRI and PET scan will be produced within 48 hours after surgery (with the aim that operative effects are not visible on the baseline scan). This corresponds to the current practice of conventional MRI follow-up at the end of the radiotherapy.
The comparison with the pre-operative scan is to assess the viability of the post-operative scan. It will assessed whether the preoperative tumor uptake will disappear in accordance to the resection, as shown by the advanced MRI sequences. In addition, it will be assessed whether there are no interfering postoperative effects. The 11C-MET-PET scans will be interpreted in comparison with the quantitative results obtained with advanced MRI sequences (perfusion / diffusion / oxygenation / spectroscopy). If an immediate postoperative 11C-MET-PET proves to be feasible, than this will provide a basis for further research. This future research consist out of the differentiation between tumor progression and therapy change, one of the most urgent clinical dilemmas in neuro-oncology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-grade Glioma Patients | – | –Patients with suspicion of newly diagnosed high-grade glioma eligible for standard therapy (surgical resection followed by chemoradiotherapy). Patients with a second brain tumor, brain surgery earlier or prior radiotherapy to the brain are excluded. Patients with only a biopsy be excluded. The group will consist of 10 patients. This number may be adjusted for patients who are found to have a different diagnosis after histological examination or fall out. For a pilot feasibility study our experience that a number of 10 patients is sufficient for PET examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion of newly diagnosed high-grade glioma eligible for standard therapy (surgical resection followed by chemoradiotherapy). Patients with a second brain tumor, brain surgery earlier or prior radiotherapy to the brain are excluded. Patients with only a biopsy be excluded. The group will consist of 10 patients. This number may be adjusted for patients who are found to have a different diagnosis after histological examination or fall out. For a pilot feasibility study our experience that a number of 10 patients is sufficient for PET examination.
Key inclusion criteria (1 listed)
- Patients with suspicion of newly diagnosed high-grade glioma who qualify for the standard treatment. Written informed consent
Key exclusion criteria (4 listed)
- Patients with recurrent high-grade glioma or other brain tumor as a secondary diagnosis are excluded.
- In addition, all patients who have had previous brain surgery or radiotherapy to the brain are also excluded.
- Patients with only a biopsy will be excluded. Patients under the age of 18 years will not be included.
- General exclusion criteria for MRI are exclusion criteria for participation in this study. The general MRI exclusion criteria are: not MRI compatible ferromagnetic material, pregnancy (or presumption thereof) and claustrophobia.
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
Visual comparison of pre- and post-surgery 11C-MET-PET
Time frame: 1 week between pre- and post-surgery 11C-MET-PET
The 11C-MET-PET within 48 hours postoperatively will be assessed visually and quantitatively and compared with the preoperative 11C-MET-PET scan. The 11C-MET-PET data will also be checked by comparison with the results of the advanced MRI sequences. Specifically the comparison will include evaluation of surgical success (all former positive 11C-MET uptake removed) and evaluation of possible post-surgical effects on the second 11C-MET-PET.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by University Medical Center Groningen.
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 1 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 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Visual comparison of pre- and post-surgery 11C-MET-PET (time frame: 1 week between pre- and post-surgery 11C-MET-PET). 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 23 Oct 2015.