Amino Acid PET-based Response Assessment in IDH-mutant Gliomas (APPEAR)

NCT07159607 | Recruiting

• 1 other identifier: 24-1114
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

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.

Conditions

IDH-mutant Glioma (Oligodendroglioma, Astrocytoma)

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment at least 24 months, maximal until end of study (max. 24 months after enrolment of last patient).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• ≥ 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
• Performance of amino acid PET as part of clinical routine

Sponsors & Collaborators

• LMU Klinikum: lead
• Servier Affaires Médicales: collaborator
• Servier Deutschland GmbH: collaborator

Study Sites (2)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

LMU Hospital

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Oligodendroglioma; Astrocytoma; Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Nathalie L Albert, Prof. Dr. med.

  LMU Klinikum München

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie L Albert, Prof. Dr. med

CONTACT

+4989440074646; Nathalie.Albert@med-uni-muenchen.de

Matthias Preusser, Prof. Dr. med.

CONTACT

+43-1-40400-44450; matthias.preusser@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 8, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): July 16, 2030
• Study Completion (Estimated): July 16, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

AU (1); DE (1)