Actively Recruiting

All Genders
NCT06214767

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

Led by Beijing Tiantan Hospital · Updated on 2025-07-30

1200

Participants Needed

1

Research Sites

304 weeks

Total Duration

On this page

Sponsors

B

Beijing Tiantan Hospital

Lead Sponsor

R

RenJi Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of CCM based on brain MRI (T1, T2, SWI, and T2-Fluid-Attenuated Inversion Recovery)
  • No previous invasive treatment such as surgery, radiotherapy, or multimodal therapy
  • Agreement to collect lesion tissue samples if undergoing surgery, with signed consent
  • Agreement to collect imaging data if under conservative observation, with signed consent
  • Willingness to participate in long-term follow-up
Not Eligible

You will not qualify if you...

  • Acute intracranial symptomatic hemorrhage requiring emergency surgery
  • Presence of other intracranial diseases like aneurysms, tumors, or vascular malformations (excluding developmental venous anomalies)
  • Severe underlying diseases affecting functional status and life expectancy
  • Severe psychiatric or psychological disorders
  • Incomplete clinical or imaging data

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

S

shuo wang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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