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

NCT07405372 | Recruiting

• 1 other identifier: 2025460
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma

Keywords

Glioma; IDH; PET/MRI

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficacy, survival analysis

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

  Completed within half year after end of the study

Interventions

Targeted IDH PET/MRI DIAGNOSTIC_TEST

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

Eligibility Criteria

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

Study Population

The subjects the investigators selected are adults who are not restricted by gender.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Related Publications (1)

• 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, and TSPO PET. Eur J Nucl Med Mol Imaging. 2024 Jul;51(8):2371-2381. doi: 10.1007/s00259-024-06654-5. Epub 2024 Feb 24.

  PMID: 38396261 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

histopathological findings obtained from biopsy or resected surgical specimens

MeSH Terms

Conditions

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

• Xiao Chen

  Daping Hospital, Army Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Chen

CONTACT

15922970174; xiaochen229@foxmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)