Study of Trial Readiness in Cavernous Angiomas with Symptomatic Hemorrhage (CASH)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-004648
NCT ID: NCT03652181
Sponsor Protocol Number: 18-004648
About this study
The purpose of this study is to set up the infrastructure for future clinical trials for patients with cavernous malformations. To do this we will be assessing the quality of MRI and data collection from patients with cavernous malformations across multiple sites in the country. At Mayo, we will be looking at new MRI "sequences" in addition to the usual sequences to see if that helps determine which cavernous malformations may bleed again.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 18 years of age and older.
- Diagnosed with a brain cavernous malformation (single or multiple).
- Had a symptomatic hemorrhage (bleed) within the past year; surgery is not anticipated.
Exclusion Criteria:
- Spinal cord cavernous malformation.
- Have received prior brain irradiation.
- Unable to verify prior cavernous malformation bleeding on MRI.
- Unable to undergo MRI with contrast because of contraindications (e.g., pacemaker, metallic foreign body, pregnancy) or other reasons (severe claustrophobia, too large for MRI scanner).
- Pregnant or breastfeeding women due to unknown harm to fetus/child from MRI with contrast.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kelly Flemming, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available