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NCT Number: NCT06214767

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

JUN WU, MD

CONTACT

[email protected]

+8613426322945

Shuo Wang, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Functional Outcome:mRS

    Time frame: 3 years

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

Secondary outcomes

  1. Radiological Outcome:Bleeding

    Time frame: 3 years

    Bleeding is defined as the presence of new hemorrhage identified on radiological imaging in patients.

  2. Radiological Outcome:Increase in lesion volume

    Time frame: 3 years

    An increase in lesion volume is defined as a 20% or more increase in the size of the lesion, as shown by follow-up imaging compared to previous measurements.

  3. Syndrome Outcome:Drug-resistant epilepsy

    Time frame: 3 years

    Epilepsy is considered drug-resistant when a person has failed to achieve sustained seizure freedom despite adequate trials of two appropriate and well-tolerated antiepileptic drug regimens, either as monotherapies or in combination.

  4. Syndrome Outcome:Focal neurological deficits

    Time frame: 3 years

    Focal neurological deficits can manifest as weakness, numbness, loss of coordination, or changes in sensation specific to the affected area, and are typically indicative of underlying neurological conditions or injuries.

  5. All-cause mortality

    Time frame: 3 years

    All-cause mortality refers to the proportion of deaths due to any cause within the follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

shuo wang

CONTACT

[email protected]

13801180330

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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