GliomaNCT07405372
Construction and Application of an IDH Mutation-Targeted PET/MRI Imaging Framework for Precision Diagnosis of Gliomas
An observational study of Glioma, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Targeted IDH PET/MRI
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects the investigators selected are adults who are not restricted by gender.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400010
Xiao Chen, Ph.D, 15922970174, xiaochen229@foxmail.com
About this study
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.
Read the detailed description
- 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).
- Conditions
- Glioma
- Being tested
- Targeted IDH PET/MRI
- Keywords
- Glioma, IDH, PET/MRI
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted IDH PET/MRIDiagnostic test
Patients with clinical suspected gliomas will receive the targeted IDH PET/MRI.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy, survival analysis
sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,
Measured: Completed within half year after end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Chen, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Xiao Chen, Principal investigator, Daping Hospital, Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405372
- Sponsor's protocol ID
- 2025460
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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, 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.
PubMed 38396261
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of an IDH Mutation-Targeted PET/MRI Imaging Framework for Precision Diagnosis of Gliomas
- ClinicalTrials.gov ID
- NCT07405372
- Acronym / sponsor ID
- 2025460
- Conditions
- Glioma
- Keywords
- Glioma, IDH, PET/MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects the investigators selected are adults who are not restricted by gender.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted IDH PET/MRIPatients with clinical suspected gliomas will receive the targeted IDH PET/MRI. | Diagnostic test | – |
Primary outcome
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,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 38396261Kaiser 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.
- Individual participant dataSharing planned: No
Related trials for Glioma
Active, not recruitingPhase 1/2
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EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao Chen principal investigator
Daping Hospital, Army Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Chen (15922970174, xiaochen229@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy, survival analysis (time frame: Completed within half year after end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07405372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.