Gliomas Harboring IDH1 and/or IDH2 MutationsNCT07608003
Multicenter Prospective Study on MRI AI Model for Midline Glioma Subtyping and Prognosis:
An observational study of Gliomas Harboring IDH1 and/or IDH2 Mutations and Glioma Glioblastoma Multiforme, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
A vision-language model using preoperative MRI and clinical variables has been developed to simultaneously predict three key molecular markers in midline gliomas: H3K27M, IDH, and 1p/19q. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gliomas Harboring IDH1 and/or IDH2 Mutations, Glioma Glioblastoma Multiforme, Glioma of Brainstem
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2026to 31 Dec 2030
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with diffuse gliomas located in the intracranial midline.
Who may be able to join
- Patients with diffuse gliomas were pathologically and molecularly diagnosed.
- The clinical case data of all patients were complete.
- Patients underwent preoperative MRI examination.
Who cannot join
- The tumor is not located in the intracranial midline.
- Cases in which MRI were incomplete or with significant noise and artifacts.
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
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Xuan Gong, MD., 0086-731-8975-3037, gong.xuan@csu.edu.cn
Shuwen Kuang, MD., 0086-13367494221, 228102171@csu.edu.cn
About this study
Official title: Application of MRI-Based Artificial Intelligence Models for Preoperative Molecular Subtyping and Prognostic Assessment of Midline Gliomas: A Multicenter Prospective Clinical Study
A vision-language model using preoperative MRI and clinical variables has been developed to simultaneously predict three key molecular markers in midline gliomas: H3K27M, IDH, and 1p/19q. This prospective multicenter study will validate the model's accuracy in preoperative molecular subtyping and its value in prognostic assessment and clinical decision-making across multiple neurosurgical centers.
Read the detailed description
This study aims to validate the clinical value of an MRI-based artificial intelligence model for personalized diagnosis and treatment in patients with midline gliomas. The model integrates preoperative MRI features with clinical variables (e.g., age, sex, and other relevant patient characteristics) to predict both molecular subtypes and patient prognosis.
Model workflow. The model takes as input tumor-containing slices from preoperative MRI sequences, along with patient age and sex. By recognizing information within the MRI sequences, the model outputs the predicted molecular diagnosis for the patient.
Primary objective. To evaluate the model's accuracy in preoperative molecular subtyping of midline gliomas (H3K27M, IDH, and 1p/19q status) by comparing its predictions with the gold standard of postoperative or post-biopsy pathology. Diagnostic performance will be assessed using sensitivity, specificity, accuracy, F1 score, and area under the receiver operating characteristic curve (AUC).
Secondary objective. To assess the model's prognostic capability by integrating imaging features with clinical variables to predict patient survival outcomes and treatment response. Prognostic performance will be evaluated using time-dependent AUC and calibration metrics.
Exploratory objective. To explore the model's added value in clinical decision-making, including its potential to guide preoperative treatment planning and risk stratification.
This prospective, multicenter study will be conducted across several tertiary neurosurgical centers in China. The findings are expected to provide high-level evidence supporting non-invasive, precise diagnosis and personalized management of midline gliomas.
- Conditions
- Gliomas Harboring IDH1 and/or IDH2 Mutations, Glioma Glioblastoma Multiforme, Glioma of Brainstem, Glioma, Diffuse Midline, H3K27M-mutant, Glioma : Oligodendroglioma or Astrocytoma, Gliomas
- Keywords
- Midline gliomas, Molecular diagnosis, Foundation model, Prognosis prediction
- Medical subject headings
- Glioblastoma, Glioma, Astrocytoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy for midline glioma molecular subtypes
Model predictions compared with postoperative histopathology and molecular testing (gold standard). Performance metrics include AUC, F1 score, sensitivity, specificity, and accuracy.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start10 May 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gliomas Harboring IDH1 and/or IDH2 MutationsStudies 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
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuan Gong, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608003
- Sponsor's protocol ID
- 2026040726
- Status last verified
- Apr 2026
- First submitted
- 7 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of MRI-Based Artificial Intelligence Models for Preoperative Molecular Subtyping and Prognostic Assessment of Midline Gliomas: A Multicenter Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07608003
- Acronym / sponsor ID
- 2026040726
- Conditions
- Gliomas Harboring IDH1 and/or IDH2 Mutations, Glioma Glioblastoma Multiforme, Glioma of Brainstem, Glioma, Diffuse Midline, H3K27M-mutant, Glioma : Oligodendroglioma or Astrocytoma, Gliomas
- Keywords
- Midline gliomas, Molecular diagnosis, Foundation model, Prognosis prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 May 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.
A vision-language model using preoperative MRI and clinical variables has been developed to simultaneously predict three key molecular markers in midline gliomas: H3K27M, IDH, and 1p/19q. This prospective multicenter study will validate the model's accuracy in preoperative molecular subtyping and its value in prognostic assessment and clinical decision-making across multiple neurosurgical centers.
Detailed description
This study aims to validate the clinical value of an MRI-based artificial intelligence model for personalized diagnosis and treatment in patients with midline gliomas. The model integrates preoperative MRI features with clinical variables (e.g., age, sex, and other relevant patient characteristics) to predict both molecular subtypes and patient prognosis.
Model workflow. The model takes as input tumor-containing slices from preoperative MRI sequences, along with patient age and sex. By recognizing information within the MRI sequences, the model outputs the predicted molecular diagnosis for the patient.
Primary objective. To evaluate the model's accuracy in preoperative molecular subtyping of midline gliomas (H3K27M, IDH, and 1p/19q status) by comparing its predictions with the gold standard of postoperative or post-biopsy pathology. Diagnostic performance will be assessed using sensitivity, specificity, accuracy, F1 score, and area under the receiver operating characteristic curve (AUC).
Secondary objective. To assess the model's prognostic capability by integrating imaging features with clinical variables to predict patient survival outcomes and treatment response. Prognostic performance will be evaluated using time-dependent AUC and calibration metrics.
Exploratory objective. To explore the model's added value in clinical decision-making, including its potential to guide preoperative treatment planning and risk stratification.
This prospective, multicenter study will be conducted across several tertiary neurosurgical centers in China. The findings are expected to provide high-level evidence supporting non-invasive, precise diagnosis and personalized management of midline gliomas.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diffuse gliomas located in the intracranial midline.
Key inclusion criteria (3 listed)
- Patients with diffuse gliomas were pathologically and molecularly diagnosed.
- The clinical case data of all patients were complete.
- Patients underwent preoperative MRI examination.
Key exclusion criteria (2 listed)
- The tumor is not located in the intracranial midline.
- Cases in which MRI were incomplete or with significant noise and artifacts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy for midline glioma molecular subtypes
Time frame: Perioperative
Model predictions compared with postoperative histopathology and molecular testing (gold standard). Performance metrics include AUC, F1 score, sensitivity, specificity, and accuracy.
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 27 May 2026.
- Individual participant dataSharing planned: No
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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.
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 Gliomas Harboring IDH1 and/or IDH2 Mutations and Glioma Glioblastoma Multiforme, run by Xiangya Hospital of Central South 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 2 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 27 May 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 Gong Xuan, MD. (0086-731-8975-3037, gong.xuan@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy for midline glioma molecular subtypes (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2026.