Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,200
- Locations
- 1
- Primary Endpoint
- Functional Outcome:mRS
Study Overview
Brief Summary
The goal of this observational study is to evaluate and predict the risk associated with cerebral cavernous malformations (CCMs) using advanced artificial intelligence and radiomics analysis technology. The study focuses on individuals who have been diagnosed with cerebral cavernous malformations (CCMs).
Main Questions to Answer:
How can AI-based radiomics features predict the risk of complications (such as bleeding or epilepsy) in individuals with CCMs? What are the most reliable imaging and clinical markers for assessing the prognosis of CCMs? Participants will be required to undergo regular medical imaging to gather traditional and radiomics imaging features.
Participants will provide clinical data, including past medical history and results of any laboratory tests.
Participants will be part of a three-year follow-up observation to monitor the progression or stability of CCMs.
Contribution of biological samples for advanced testing might also be requested.
This study aims to create an AI-based decision-making tool that will guide clinicians in the management of CCM, with the potential to significantly improve patient outcomes through personalized medical approaches.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of CCM based on brain MRI (T1, T2, SWI, and T2-Fluid-Attenuated Inversion Recovery).
- •Patients who have not received invasive treatment (surgery, radiotherapy, or multimodal therapy) in the past.
- •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.
- •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.
- •Willingness to participate in long-term follow-up.
Exclusion Criteria
- •Patients with acute intracranial symptomatic hemorrhage requiring emergency surgery.
- •Patients with other intracranial diseases, such as aneurysms, tumors, or other vascular malformations, excluding developmental venous anomalies (DVA).
- •Patients with severe underlying diseases affecting their functional status and short-term life expectancy.
- •Patients with severe psychiatric or psychological disorders.
- •Incomplete clinical or imaging data.
Outcomes
Primary Outcomes
Functional Outcome:mRS
Time Frame: 3 years
Last follow-up with a modified Rankin Scale (mRS) score greater than 2 persisting for at least one year
Secondary Outcomes
- Radiological Outcome:Bleeding(3 years)
- Radiological Outcome:Increase in lesion volume(3 years)
- All-cause mortality(3 years)
- Syndrome Outcome:Drug-resistant epilepsy(3 years)
- Syndrome Outcome:Focal neurological deficits(3 years)
Investigators
Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Beijing Tiantan Hospital