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

NCT06214767 | Recruiting

• 1 other identifier: HX-B-2023058
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemangioma, Cavernous, Central Nervous System

Outcome Measures

Primary Outcomes (1)

• Functional Outcome:mRS

  Last follow-up with a modified Rankin Scale (mRS) score greater than 2 persisting for at least one year

  3 years

Secondary Outcomes (5)

• Radiological Outcome:Bleeding

  3 years

• Radiological Outcome:Increase in lesion volume

  3 years

• Syndrome Outcome:Drug-resistant epilepsy

  3 years

• Syndrome Outcome:Focal neurological deficits

  3 years

• All-cause mortality

  3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Untreated cerebral cavernous malformation patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• RenJi Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Guangzhou Red Cross Hospital: collaborator
• Affiliated Hospital of Guangdong Medical University: collaborator
• Shanxi Provincipal People's Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator

Study Sites (1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Hemangioma, Cavernous, Central Nervous System

Condition Hierarchy (Ancestors)

Hemangioma, Cavernous; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Cavernous Sinus Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Hemostatic Disorders; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

shuo wang

CONTACT

13801180330; captain9858@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: September 1, 2020
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

CN (1)