IDH-mutant Glioma (Oligodendroglioma, Astrocytoma)
Conditions
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
Brief 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 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.
Interventions
None listed
Sponsors
Servier Affaires Médicales
Servier Deutschland GmbH
LMU Klinikum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 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
Exclusion criteria
* Inclusion in another clinical trial/investigational study involving an experimental therapy or study medication * Inclusion criteria not met
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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. |
Countries
Austria, Germany
Contacts
Primary ContactNathalie L Albert, Prof. Dr. med
Backup ContactMatthias Preusser, Prof. Dr. med.
Outcome results
None listed