Study of Trial Readiness in Cavernous Angiomas with Symptomatic Hemorrhage (CASH)

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kelly Flemming, M.D.

Open for enrollment

Contact information:

Bambi Wessel

(507)293-1963

Wessel.Bambi@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20438461

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