GlioblastomaNCT05753995
Immuno-Positron Emission Tomography (PET)-Glioma Study, a Proof-of-principle Imaging Study
A study testing PET imaging in people with Glioblastoma, run by Kepler University Hospital at 1 site in Austria.
Trial summary
Imaging of proinflammatory activated microglia by Purine 2X7 (P2X7) receptor scintigraphy in Positron Emission Tomography (PET) scanner in Glioblastoma patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma
- What is being tested?
- PET imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a new probable diagnosis of glioblastoma based on MRI imaging.
- prior to initiation of specific tumor therapy and prior to any surgery (including biopsy)
- short-term medication for cerebral edema (including corticosteroids) and short-term administration of antiepileptic drugs are not a reason for exclusion
Who cannot join
- Non-business capacity
- Pregnancy
- breastfeeding period
- Other malignant disease (active)
- Concurrent participation in another clinical trial
- Foreseeable compliance problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging of Proinflammatory Activated Microglia Using Purine 2X7 (P2X7) Receptor Scintigraphy in Immuno-Positron Emission Tomography (PET) Scanner in Glioblastoma Patients: a Proof-of-principle Imaging Study
Imaging of proinflammatory activated microglia by Purine 2X7 (P2X7) receptor scintigraphy in Positron Emission Tomography (PET) scanner in Glioblastoma patients.
Read the detailed description
Glioblastomas are extremely malignant tumors of the brain; despite different therapeutic approaches, the median survival is only about 1 ½ years. This makes the need for action to investigate the mechanisms of action of new drug approaches all the more urgent. In the therapy of malignant intracerebral neoplasms, immunological processes between tumor and endogenous immune response represent a key phenomenon for understanding response.
In the CheckMate-143 trial, an anti-programmed cell death-1 monoclonal antibody disappointed by ineffectiveness in the vast majority of Glioblastoma patients (although a minority benefited significantly). This will be largely explained by the immunological milieu of the tumor. One-third of the cells in Glioblastoma constitute the microglia or monocyte cell population. These immunocompetent cells also serve as a protective shield for the Glioblastoma against a possible therapy-induced endogenous immune response.
Corresponding research is being conducted preclinically on cell cultures, brain tissue samples (immunohistochemistry, autoradiography) and in animal models. A major role is played by microglial cells, which perform the immunocompetent function in the brain. Microglia and monocytes have an activation state as well as an opposite of a suppressive one in their immunological function. This M1 or M2 concept is similar to the old postulated Th1 or Th2 principle in lymphocytes. Different purinergic receptors -P2Y12R and Purine receptor 2XR - are active here, respectively. Recently, antibody-based positron-emitter-labeled tracers have been developed for this purpose and thus, in principle, positron emission tomography (PET) imaging in vivo is possible.
The subsequent clinical relevance of a better understanding of these processes would consist in a combined therapeutic concept, in which additionally an immunomodulation in the desired direction of the regional activity of the immunocompetent cells could take place.
Methods for in vivo imaging of activated microglia in positron emission computed tomography scanners (PET) have already been developed - e.g. translocator protein positron emission tomography (TSPO-PET) by detecting mitochondrial activation of microglial cells. Here, however, it is not possible to distinguish between pro- and anti-inflammatory function of the immunocompetent cells. However, it is possible to do so by specific receptor recognition. For example, the purinergic receptor P2X7 is only expressed during proinflammatory activity. For this purpose, the positron emission tomography scanners (PET) tracer [18-Fluorine] Johnson \& Johnson (JNJ)-64413739 has been developed in the academic research field. Patient cohort studies are still pending in this regard. Our intention is to investigate in patients with untreated Glioblastoma whether effective imaging of immunological disease activity is possible in this way.
- Conditions
- Glioblastoma
- Being tested
- PET imaging
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET imagingDiagnostic test
The evaluation of PET imaging using PET ligand [18F]JNJ-64413739 or a [18F] labeled equivalent in vivo in patients.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | for diagnostic Receives: Diagnostic Test: PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immuno PET can be used to visualize the immunological environment of the tumor (Glioblastoma).
Thus, the aim of the pilot study, which follows an exploratory approach, is to evaluate PET imaging in vivo in patients using PET ligand [18F]JNJ-64413739 or a [18F] labeled equivalent.
To evaluate if it is possible to visualize (visually topically deniable increased Tracer-uptake) the immunological processes in tumor or adjacent brain structures in sufficient image quality.
We practice measurement by SUV (= standard uptake value) of the morphologically identified glioblastoma lesion relative to normal brain tissue: TBR (=tumor background ratio) - as a quantification of immunological processes inside the tumor.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Mar 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Pichler, PD, MD, Principal investigator, Kepler University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753995
- Sponsor's protocol ID
- Immuno-PET-Glioma study
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Proinflammatory Activated Microglia Using Purine 2X7 (P2X7) Receptor Scintigraphy in Immuno-Positron Emission Tomography (PET) Scanner in Glioblastoma Patients: a Proof-of-principle Imaging Study
- ClinicalTrials.gov ID
- NCT05753995
- Acronym / sponsor ID
- Immuno-PET-Glioma study
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Mar 2023 (actual)
- 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.
Imaging of proinflammatory activated microglia by Purine 2X7 (P2X7) receptor scintigraphy in Positron Emission Tomography (PET) scanner in Glioblastoma patients.
Detailed description
Glioblastomas are extremely malignant tumors of the brain; despite different therapeutic approaches, the median survival is only about 1 ½ years. This makes the need for action to investigate the mechanisms of action of new drug approaches all the more urgent. In the therapy of malignant intracerebral neoplasms, immunological processes between tumor and endogenous immune response represent a key phenomenon for understanding response.
In the CheckMate-143 trial, an anti-programmed cell death-1 monoclonal antibody disappointed by ineffectiveness in the vast majority of Glioblastoma patients (although a minority benefited significantly). This will be largely explained by the immunological milieu of the tumor. One-third of the cells in Glioblastoma constitute the microglia or monocyte cell population. These immunocompetent cells also serve as a protective shield for the Glioblastoma against a possible therapy-induced endogenous immune response.
Corresponding research is being conducted preclinically on cell cultures, brain tissue samples (immunohistochemistry, autoradiography) and in animal models. A major role is played by microglial cells, which perform the immunocompetent function in the brain. Microglia and monocytes have an activation state as well as an opposite of a suppressive one in their immunological function. This M1 or M2 concept is similar to the old postulated Th1 or Th2 principle in lymphocytes. Different purinergic receptors -P2Y12R and Purine receptor 2XR - are active here, respectively. Recently, antibody-based positron-emitter-labeled tracers have been developed for this purpose and thus, in principle, positron emission tomography (PET) imaging in vivo is possible.
The subsequent clinical relevance of a better understanding of these processes would consist in a combined therapeutic concept, in which additionally an immunomodulation in the desired direction of the regional activity of the immunocompetent cells could take place.
Methods for in vivo imaging of activated microglia in positron emission computed tomography scanners (PET) have already been developed - e.g. translocator protein positron emission tomography (TSPO-PET) by detecting mitochondrial activation of microglial cells. Here, however, it is not possible to distinguish between pro- and anti-inflammatory function of the immunocompetent cells. However, it is possible to do so by specific receptor recognition. For example, the purinergic receptor P2X7 is only expressed during proinflammatory activity. For this purpose, the positron emission tomography scanners (PET) tracer [18-Fluorine] Johnson \& Johnson (JNJ)-64413739 has been developed in the academic research field. Patient cohort studies are still pending in this regard. Our intention is to investigate in patients with untreated Glioblastoma whether effective imaging of immunological disease activity is possible in this way.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Diagnostic Test: PET imagingfor diagnostic |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a new probable diagnosis of glioblastoma based on MRI imaging.
- prior to initiation of specific tumor therapy and prior to any surgery (including biopsy)
- short-term medication for cerebral edema (including corticosteroids) and short-term administration of antiepileptic drugs are not a reason for exclusion
Key exclusion criteria (6 listed)
- Non-business capacity
- Pregnancy
- breastfeeding period
- Other malignant disease (active)
- Concurrent participation in another clinical trial
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 |
|---|---|---|
| PET imagingThe evaluation of PET imaging using PET ligand [18F]JNJ-64413739 or a [18F] labeled equivalent in vivo in patients. | Diagnostic test | single arm |
Primary outcome
Immuno PET can be used to visualize the immunological environment of the tumor (Glioblastoma).
Time frame: 1-2 years
Thus, the aim of the pilot study, which follows an exploratory approach, is to evaluate PET imaging in vivo in patients using PET ligand [18F]JNJ-64413739 or a [18F] labeled equivalent. To evaluate if it is possible to visualize (visually topically deniable increased Tracer-uptake) the immunological processes in tumor or adjacent brain structures in sufficient image quality. We practice measurement by SUV (= standard uptake value) of the morphologically identified glioblastoma lesion relative to normal brain tissue: TBR (=tumor background ratio) - as a quantification of immunological processes inside the tumor.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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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.
Robert Pichler, PD, MD principal investigator
Kepler University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET imaging in people with Glioblastoma, run by Kepler University Hospital at 1 site in Austria.
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
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?
Immuno PET can be used to visualize the immunological environment of the tumor (Glioblastoma). (time frame: 1-2 years). 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 1 Apr 2025.