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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400010, China

Location status: Recruiting

Location contact

Xiao Chen, Ph.D

CONTACT

[email protected]

15922970174

About this study

Clinical and biological data: The records include all patients' general clinical information, disease course, and other imaging findings.
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.
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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Targeted IDH PET/MRI

Diagnostic Test

Patients with clinical suspected gliomas will receive the targeted IDH PET/MRI.

Primary outcomes

Diagnostic efficacy, survival analysis

Time frame: Completed within half year after end of the study

sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Chen

CONTACT

[email protected]

15922970174

Sponsors and collaborators

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Feb 12, 2026
Registry last updated: Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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