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

Capital Medical University

Status: Enrolling

Conditions: Hemangioma, Cavernous, Central Nervous System

Study type: Observational

Funder types: Other

Identifiers

NCT06214767

HX-B-2023058

Details and patient eligibility

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.

Enrollment: 1,200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.