Construction and Application of an IDH Mutation-Targeted PET/MRI Imaging Framework for Precision Diagnosis of Gliomas

Overview

Glioma is the most common primary intracranial tumor in adults, with high-grade gliomas accounting for more than 50% of all gliomas and having the highest mortality rate. The molecular characteristics of gliomas are closely associated with the selection of treatment regimens, therapeutic efficacy, and patient prognosis. Mutations in isocitrate dehydrogenase (IDH) are an important diagnostic marker for diffuse gliomas and a key component in distinguishing and defining glioma subtypes. Furthermore, the advent of IDH-targeting inhibitors has brought hope to patients with IDH-mutant gliomas. Therefore, accurately assessing the IDH mutation status of gliomas is a prerequisite and key to precision diagnosis, targeted therapy, and prognostic evaluation. This study explores the application value of targeted IDH PET/MRI imaging in glioma subtype diagnosis, tumor grading, and prognostic evaluation. It aims to establish a non-invasive in vivo tracing technology platform and evaluation system for accurately assessing glioma IDH mutation status, subtype diagnosis, and prognostic evaluation. This will provide a basis for the precise diagnosis of gliomas, the selection of targeted treatment regimens, and prognostic assessment, and promote future research and development of therapeutic drugs using labeled therapeutic radionuclides.

Detailed description

1. Clinical and biological data: The records include all patients' general clinical information, disease course, and other imaging findings. 2. PET image analysis: Record and assess lesion location, size, maximum standardized uptake (SUVmax), and target-to-species ratio (TBR), where the TBR value is calculated by dividing the SUVmax of the lesion by the background SUVmean. 3. Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the status of isocitrate dehydrogenase (IDH).

Interventions

• Diagnostic test Targeted IDH PET/MRI
  Patients with clinical suspected gliomas will receive the targeted IDH PET/MRI.

Primary outcome measures

• Diagnostic efficacy, survival analysis [Time frame: Completed within half year after end of the study]

Eligibility criteria

Inclusion criteria

• Patient ≥ 18 years of age at the time of consent;
• Patients with suspected, newly diagnosed, or previously treated gliomas;
• Provided written informed consent authorisation before participating in the study.

Exclusion criteria

• Pregnancy or lactation;
• MRI contraindications, not limited to cardiac implantable electronic devices and claustrophobia;
• Participants with radiation exposure exceeding 50 mSv in the past year.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

China · 1 center

• Department of Nuclear Medicine, Daping Hospital of Army Medical University — Chongqing

Publications

• Kaiser L, Quach S, Zounek AJ, Wiestler B, Zatcepin A, Holzgreve A, Bollenbacher A, Bartos LM, Ruf VC, Boning G, Thon N, Herms J, Riemenschneider MJ, Stocklein S, Brendel M, Rupprecht R, Tonn JC, Bartenstein P, von Baumgarten L, Ziegler S, Albert NL. Enhancing predictability of IDH mutation status in glioma patients at initial diagnosis: a comparative analysis of radiomics from MRI, [18F]FET PET, a PMID 38396261

Identifiers

NCT: NCT07405372 · 2025460

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗