Evaluating treatment decisions and prognosis for untreated cerebral cavernous malformations
Official title: Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations
Run by Beijing Tiantan Hospital · NCT06214767 · Data updated 2026-11-12
This study is trying to see how untreated cerebral cavernous malformations affect people over three years by using advanced imaging and collecting health information to better understand their risks and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 1, 2020 |
| Main results expected | September 30, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | July 30, 2025 |
| Trial ID | NCT06214767 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with CCMs who have not received any invasive treatments.
✕Probably not a fit
Patients with acute intracranial hemorrhage or other significant intracranial diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the risks associated with cerebral cavernous malformations (CCMs) using advanced artificial intelligence and radiomics analysis. Participants diagnosed with CCMs will undergo regular medical imaging to collect both traditional and radiomics imaging features, alongside providing clinical data and biological samples. The study will follow participants for three years to monitor the progression or stability of their condition and to identify reliable imaging and clinical markers for prognosis.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with cerebral cavernous malformations.
How similar studies have gone: While the use of AI and radiomics in medical imaging is a growing field, this specific approach to predicting risks in CCMs is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of CCM based on brain MRI (T1, T2, SWI, and T2-Fluid-Attenuated Inversion Recovery). 2. Patients who have not received invasive treatment (surgery, radiotherapy, or multimodal therapy) in the past. 3. Patients undergoing surgery, or their legal guardians, agree to collect lesion tissue samples for related studies and sign a consent form for the collection of biological samples. 4. Patients under conservative observation, or their legal guardians, agree to collect imaging data for related research and sign a consent form for the use of imaging data. 5. Willingness to participate in long-term follow-up. Exclusion Criteria: 1. Patients with acute intracranial symptomatic hemorrhage requiring emergency surgery. 2. Patients with other intracranial diseases, such as aneurysms, tumors, or other vascular malformations, excluding developmental venous anomalies (DVA). 3. Patients with severe underlying diseases affecting their functional status and short-term life expectancy. 4. Patients with severe psychiatric or psychological disorders. 5. Incomplete clinical or imaging data.
Where it's running
-
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: shuo wang
- Email: captain9858@126.com
- Phone: 13801180330
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.