RecruitingNCT06214767

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

Sponsor

Beijing Tiantan Hospital

Enrollment

1,200 participants

Start Date

Sep 1, 2020

Study Type

OBSERVATIONAL

Conditions

Hemangioma, Cavernous, Central Nervous System

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This is an observational study (no experimental treatment is given) for people with cerebral cavernous malformations (CCMs) — small, blood-filled clusters of abnormal blood vessels in the brain that can cause headaches, seizures, or bleeding. The study is collecting data on how doctors make treatment decisions and how patients do over time, whether they choose surgery or watchful waiting. **You may be eligible if...** - You have been diagnosed with a cerebral cavernous malformation based on a brain MRI - You have never had surgery, radiation, or other invasive treatment for your CCM - You are willing to participate in long-term follow-up - You (or your guardian) are willing to allow tissue or imaging data to be used for research **You may NOT be eligible if...** - You are having an emergency because of acute bleeding in the brain requiring immediate surgery - You have another brain condition such as an aneurysm, brain tumor, or other vascular malformation (other than developmental venous anomalies) - You have severe psychiatric illness or very poor overall health - Your clinical or imaging records are incomplete Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

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NCT06214767