Hemangioma, Cavernous, Central Nervous SystemNCT06214767
Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations
An observational study of Hemangioma, Cavernous, Central Nervous System, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemangioma, Cavernous, Central Nervous System
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Untreated cerebral cavernous malformation patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality
JUN WU, MD, +8613426322945, wujunslf@126.com
Shuo Wang, MD
About this study
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:
Read more
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.
- Medical subject headings
- Hemangioma, Cavernous, Central Nervous System
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome:mRS
Last follow-up with a modified Rankin Scale (mRS) score greater than 2 persisting for at least one year
Measured: 3 years
Secondary outcomes (5)
Radiological Outcome:Bleeding
Bleeding is defined as the presence of new hemorrhage identified on radiological imaging in patients.
Measured: 3 years
Radiological Outcome:Increase in lesion volume
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.
Measured: 3 years
Syndrome Outcome:Drug-resistant epilepsy
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.
Measured: 3 years
Syndrome Outcome:Focal neurological deficits
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.
Measured: 3 years
All-cause mortality
All-cause mortality refers to the proportion of deaths due to any cause within the follow-up period.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Sep 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemangioma, Cavernous, Central Nervous SystemStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or 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
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214767
- Sponsor's protocol ID
- HX-B-2023058
- Status last verified
- Jul 2025
- First submitted
- 10 Jan 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations
- ClinicalTrials.gov ID
- NCT06214767
- Acronym / sponsor ID
- HX-B-2023058
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or 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
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Untreated cerebral cavernous malformation patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Radiological Outcome:Bleeding
Time frame: 3 years
Radiological Outcome:Increase in lesion volume
Time frame: 3 years
Syndrome Outcome:Drug-resistant epilepsy
Time frame: 3 years
Syndrome Outcome:Focal neurological deficits
Time frame: 3 years
All-cause mortality
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemangioma, Cavernous, Central Nervous System, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shuo wang (13801180330, captain9858@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcome:mRS (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.