Evaluating treatment decisions and prognosis for untreated cerebral cavernous malformations
Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations
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 |
|---|---|
| Enrollment | 1200 (estimated) |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06214767 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with CCMs who have not received any invasive treatments.
Not a fit: Patients with acute intracranial hemorrhage or other significant intracranial diseases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Capital Medical University Affiliated Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: shuo wang
- Email: captain9858@126.com
- Phone: 13801180330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.