NCT04076449: CRESS

Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy

Recruiting now Last updated 4 September 2019

What this trial tests

trial in Cavernous Malformation, Cerebral in 200 participants. Currently enrolling.

Timeline

3 September 2019

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	yuanli Zhao
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	200
Start date	3 September 2019
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	2 locations across China

Conditions studied

• Cavernous Malformation, Cerebral — all drugs for Cavernous Malformation, Cerebral →
• Cavernous Angioma — all drugs for Cavernous Angioma →
• Cavernous Hemangioma — all drugs for Cavernous Hemangioma →
• Cavernous Hemangioma of Brain — all drugs for Cavernous Hemangioma of Brain →

Sponsor

yuanli Zhao — full company profile →

Who can join

Adults 18 to 70, any sex, with Cavernous Malformation, Cerebral or Cavernous Angioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cerebral cavernous malformation (CCM)-related epilepsy (CRE) impairs the quality of life in patients with CCM. Patients could not always achieve seizure freedom after surgical resection of the lesion, suggesting an inadequate treatment and evaluation of the epileptogenic zone or network. Iron deposition in cerebral cavernous malformations has been postulated to play an important role in triggering CRE. Quantitative susceptibility mapping (QSM), as an optimal in vivo imaging technique to quantify iron deposition, is employed to analyze the iron quantity in CCM patients with epilepsy and further combined with brain structural and connectome analysis, to describe the difference between CCMs with and without epilepsy. In vivo biomarkers predicting CRE risk in CCM natural history and CRE control outcome after CCM surgical resection will be further identified to improve management strategy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Morbidity After Symptomatic Hemorrhage of Cerebral Cavernous Malformation: A Nomogram Approach to Risk Assessment.
   Ma L, Zhang S, Li Z, Wu CX, et al · · 2020 · cited 13× · PMID 32951540 · DOI 10.1161/strokeaha.120.029942
2. Venous Architecture Predicts Hemorrhage Risk in Sporadic CCM With DVA.
   Liu Y, Wen Z, Yuan J, Ma L, et al · · 2025 · PMID 40899314 · DOI 10.1161/strokeaha.125.052339