IDH-mutant Glioma (Oligodendroglioma, Astrocytoma)APPEARNCT07159607
Amino Acid PET-based Response Assessment in IDH-mutant Gliomas (APPEAR)
An observational study of IDH-mutant Glioma (Oligodendroglioma, Astrocytoma), run by LMU Klinikum at 2 sites in 2 countries.
Trial summary
Background: The radiological follow-up of diffuse gliomas is challenged by the difficult distinction of true progression from treatment-related changes. To this end, the Response Assessment in Neuro-Oncology (RANO) Working Group has issued specific recommendation for the standardized evaluation of magnetic resonance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IDH-mutant Glioma (Oligodendroglioma, Astrocytoma)
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Jul 2025to 16 Jul 2030
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (age ≥ 18 years) patients diagnosed and/or treated at the Medical University of Vienna (Vienna, Austria) or the LMU Hospital Munich (Munich, Germany) with histologically verified diffuse IDH-mutant glioma (oligodendroglioma, CNS WHO grades 2 and 3; astrocytoma, CNS WHO grades 2, 3 and 4) and PET imaging for routinely performed response assessment before, during and after first-line treatment will be included after obtaining informed consent. In total, we expect the inclusion of 100 patients over an accrual period of 3 years.
Who may be able to join
- ≥ 18 years
- Histologically verified diffuse IDH-mutant glioma (astrocytoma, oligodendroglioma) of any grade as defined in the WHO classification of tumors of the central nervous system
- Postoperative treatment according to current standard of care at the time of study inclusion
- Performance of amino acid PET as part of clinical routine
Who cannot join
- Inclusion in another clinical trial/investigational study involving an experimental therapy or study medication
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Matthias Preusser, Prof. Dr., +43-1-40400-44450, matthias.preusser@meduniwien.ac.at
Germany1 site, 1 recruiting
- Recruiting
LMU Hospital
Munich, Bavaria, 81377
Nathalie L Albert, Prof. Dr., +49 89 4400 74685, nathalie.albert@med.uni-muenchen.de
About this study
Official title: Positron Emission Tomography-based Response Assessment in Isocitrate Dehydrogenase (IDH)-Mutant Gliomas - a Bicentric, Prospective, Observational Study
Background: The radiological follow-up of diffuse gliomas is challenged by the difficult distinction of true progression from treatment-related changes. To this end, the Response Assessment in Neuro-Oncology (RANO) Working Group has issued specific recommendation for the standardized evaluation of magnetic resonance imaging (MRI). In addition, positron emission tomography (PET) using radiolabeled amino acids allows for the delineation of metabolically active tumor regions in brain tumors, and guidelines for PET-based response assessment have been recently proposed (PET RANO 1.0). However, well-annotated data on longitudinal PET alterations before and during treatment and follow-up are missing in isocitrate dehydrogenase (IDH)-mutant gliomas, particularly as tumor entities defined by IDH mutations have been established only recently and data on PET imaging mainly rely on previous brain tumor classification frameworks.
Aims: This bicentric, prospective, observational study aims to collect data on imaging-based disease monitoring in patients with IDH-mutant gliomas. Specifically, this study aims to investigate longitudinal changes of amino acid PET tracer uptake during treatment in IDH-mutant gliomas and to evaluate the correlation between amino acid PET uptake at baseline and response to postoperative standard of care treatment.
Read more
Patient cohort/methods: Adult (age ≥ 18 years) patients diagnosed and/or treated at the Medical University of Vienna (Vienna, Austria) or the LMU Hospital Munich (Munich, Germany) with histologically verified diffuse IDH-mutant glioma (oligodendroglioma, astrocytoma of all grades) and PET imaging for routine follow-up before, during and after treatment will be included. Clinical and imaging data will be collected in a standardized manner and correlated with treatment response. Primary endpoint is progression-free survival (PFS) according to RANO 2.0 criteria, secondary endpoints include PFS according to PET-RANO 1.0 criteria, time to next intervention (TTNI) and overall survival (OS).
Originality/relevance: This study will generate data that will inform future response assessment frameworks and the design of future clinical trials in IDH-mutant glioma.
- Keywords
- APPEAR, PET-basierte Beurteilung des Therapieansprechens in Isocitrat-Dehydrogenase (IDH)-mutierten Gliomen - eine prospektive Beobachtungsstudie, Isocitrate dehydrogenase mutant gliomas, Positron emission tomography, FET PET, PET RANO, Amino acid PET, glioma
- Medical subject headings
- Oligodendroglioma, Astrocytoma, Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PET image information at baseline and follow-up as well as responses according to PET RANO 1.0 criteria will be correlated with progression-free survival (PFS) according to RANO 2.0 criteria.
Measured: From enrollment at least 24 months, maximal until end of study (max. 24 months after enrolment of last patient).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start17 Jul 2025
- Primary completion16 Jul 2030 (estimated)
- Study completion16 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IDH-mutant Glioma (Oligodendroglioma, Astrocytoma)Studies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- Servier Affaires Médicales, Servier Deutschland GmbH
- Responsible party
- Principal investigator, Nathalie Albert, LMU Klinikum
- Investigators
- Nathalie L Albert, Prof. Dr. med., Principal investigator, LMU Klinikum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159607
- Sponsor's protocol ID
- 24-1114
- Acronym
- APPEAR
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be considered upon reasonable request, depending on ethics approval
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography-based Response Assessment in Isocitrate Dehydrogenase (IDH)-Mutant Gliomas - a Bicentric, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07159607
- Acronym / sponsor ID
- APPEAR / 24-1114
- Keywords
- APPEAR, PET-basierte Beurteilung des Therapieansprechens in Isocitrat-Dehydrogenase (IDH)-mutierten Gliomen - eine prospektive Beobachtungsstudie, Isocitrate dehydrogenase mutant gliomas, Positron emission tomography, FET PET, PET RANO, Amino acid PET, glioma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Collaborators
- Servier Affaires Médicales, Servier Deutschland GmbH
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 16 Jul 2030 (estimated)
- Study completion
- 16 Jul 2030 (estimated)
- First posted
- 8 Sep 2025 (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.
Background: The radiological follow-up of diffuse gliomas is challenged by the difficult distinction of true progression from treatment-related changes. To this end, the Response Assessment in Neuro-Oncology (RANO) Working Group has issued specific recommendation for the standardized evaluation of magnetic resonance imaging (MRI). In addition, positron emission tomography (PET) using radiolabeled amino acids allows for the delineation of metabolically active tumor regions in brain tumors, and guidelines for PET-based response assessment have been recently proposed (PET RANO 1.0). However, well-annotated data on longitudinal PET alterations before and during treatment and follow-up are missing in isocitrate dehydrogenase (IDH)-mutant gliomas, particularly as tumor entities defined by IDH mutations have been established only recently and data on PET imaging mainly rely on previous brain tumor classification frameworks.
Aims: This bicentric, prospective, observational study aims to collect data on imaging-based disease monitoring in patients with IDH-mutant gliomas. Specifically, this study aims to investigate longitudinal changes of amino acid PET tracer uptake during treatment in IDH-mutant gliomas and to evaluate the correlation between amino acid PET uptake at baseline and response to postoperative standard of care treatment.
Patient cohort/methods: Adult (age ≥ 18 years) patients diagnosed and/or treated at the Medical University of Vienna (Vienna, Austria) or the LMU Hospital Munich (Munich, Germany) with histologically verified diffuse IDH-mutant glioma (oligodendroglioma, astrocytoma of all grades) and PET imaging for routine follow-up before, during and after treatment will be included. Clinical and imaging data will be collected in a standardized manner and correlated with treatment response. Primary endpoint is progression-free survival (PFS) according to RANO 2.0 criteria, secondary endpoints include PFS according to PET-RANO 1.0 criteria, time to next intervention (TTNI) and overall survival (OS).
Originality/relevance: This study will generate data that will inform future response assessment frameworks and the design of future clinical trials in IDH-mutant glioma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (age ≥ 18 years) patients diagnosed and/or treated at the Medical University of Vienna (Vienna, Austria) or the LMU Hospital Munich (Munich, Germany) with histologically verified diffuse IDH-mutant glioma (oligodendroglioma, CNS WHO grades 2 and 3; astrocytoma, CNS WHO grades 2, 3 and 4) and PET imaging for routinely performed response assessment before, during and after first-line treatment will be included after obtaining informed consent. In total, we expect the inclusion of 100 patients over an accrual period of 3 years.
Key inclusion criteria (4 listed)
- ≥ 18 years
- Histologically verified diffuse IDH-mutant glioma (astrocytoma, oligodendroglioma) of any grade as defined in the WHO classification of tumors of the central nervous system
- Postoperative treatment according to current standard of care at the time of study inclusion
- Performance of amino acid PET as part of clinical routine
Key exclusion criteria (1 listed)
- Inclusion in another clinical trial/investigational study involving an experimental therapy or study medication
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
Progression-free survival
Time frame: From enrollment at least 24 months, maximal until end of study (max. 24 months after enrolment of last patient).
PET image information at baseline and follow-up as well as responses according to PET RANO 1.0 criteria will be correlated with progression-free survival (PFS) according to RANO 2.0 criteria.
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 8 Sep 2025.
- Individual participant dataSharing planned: Undecided. IPD may be considered upon reasonable request, depending on ethics approval
Related trials for IDH-mutant Glioma (Oligodendroglioma, Astrocytoma)
RecruitingPhase 2
Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease
Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma
RecruitingPhase 3
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
Glioma, Astrocytoma, Grade IV
Not yet recruitingPhase 2
Safusidenib for Patients With Newly Diagnosed IDH1-mutant CNS WHO Grade 3 Oligodendroglioma and Astrocytoma - a Single Arm Phase II Study
Glioma : Oligodendroglioma or Astrocytoma
Active, not recruitingPhase 2
Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma
Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma
Not yet recruitingPhase 3
Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma
Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2
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.
Nathalie L Albert, Prof. Dr. med. principal investigator
LMU Klinikum München
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IDH-mutant Glioma (Oligodendroglioma, Astrocytoma), run by LMU Klinikum at 2 sites in 2 countries.
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 1 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, 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?
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?
Contact Nathalie L Albert, Prof. Dr. med (+4989440074646, Nathalie.Albert@med-uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From enrollment at least 24 months, maximal until end of study (max. 24 months after enrolment of last patient).). 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 8 Sep 2025.