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

NCT06214767 — Recruiting, 1200 participants, Beijing Tiantan Hospital
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RegistryNCT06214767
StatusRecruiting
Study typeObservational
Enrollment1200 (Estimated)
SponsorBeijing Tiantan Hospital (Other); collaborators: RenJi Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital, Guangzhou Red Cross Hospital, Affiliated Hospital of Guangdong Medical University, Shanxi Provincial People's Hospital, Qilu Hospital of Shandong University, Second Xiangya Hospital of Central South University, First Affiliated Hospital of Harbin Medical University
ConditionsHemangioma, Cavernous, Central Nervous System
Datesstart 2020-09-01, primary completion 2025-09-30 (estimated), completion 2026-06-30 (estimated), first posted 2024-01-22, last updated 2025-07-30
Locations1 site in China

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-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.

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+Outcome measures

Primary outcomes

  • Functional Outcome:mRS [3 years]: Last follow-up with a modified Rankin Scale (mRS) score greater than 2 persisting for at least one year

Secondary outcomes

  • Radiological Outcome:Bleeding [3 years]: Bleeding is defined as the presence of new hemorrhage identified on radiological imaging in patients.
  • Radiological Outcome:Increase in lesion volume [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.
  • Syndrome Outcome:Drug-resistant epilepsy [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.
  • Syndrome Outcome:Focal neurological deficits [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.
  • All-cause mortality [3 years]: All-cause mortality refers to the proportion of deaths due to any cause within the follow-up period.

+Eligibility

Sex: All

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.

+Locations (1)

FacilityCityCountryStatus
Capital Medical University Affiliated Beijing Tiantan HospitalBeijing, Beijing MunicipalityChinaRecruiting

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