Clinical trial · Observational
Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemangioma, Cavernous, Central Nervous System | Hemangioma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Functional Outcome:mRS
- timeFrame
- 3 years
- description
- Last follow-up with a modified Rankin Scale (mRS) score greater than 2 persisting for at least one year
Secondary outcomes (5)
- measure
- Radiological Outcome:Bleeding
- timeFrame
- 3 years
- description
- Bleeding is defined as the presence of new hemorrhage identified on radiological imaging in patients.
- measure
- Radiological Outcome:Increase in lesion volume
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available