Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06214767
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Tiantan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hemangioma, Cavernous, Central Nervous System

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Recruiting

Address

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing,

Site Contact

JUN WU, MD

[email protected]

+8613426322945

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