Official Title
Validation of Core Biopsy of Vascular Anomalies for Clinical Pathology and Genomics
Brief Title
Vascular Anomaly Pathology and Genomics Biopsy Study
Protocol ID
NCT04836884
Lead Sponsor
Mayo Clinic
Brief Summary
The purpose of this research is to gather information on the safety and effectiveness of
core biopsy of vascular anomalies for clinical pathology and clinical genomics studies.
Detailed Description
Vascular anomalies or vascular malformations often are treated with minimally invasive
sclerotherapy, embolization or ablation based on clinical and imaging features without
acquisition of tissue. Over the last two decades there have been significant advancements
in the understanding of the genetic basis for various vascular anomalies/malformations,
which may guide use of therapies for individualized treatment.
As such, given the emergence of novel medications for treatment of vascular
anomalies/malformations based on genetic information, acquisition of tissue for pathology
and genomic characterization will be increasingly important as treatment of vascular
anomalies/vascular malformations moves toward individualized medicine approach.
Study Period
-
Enrollment Count
3 participants
Eligibility Criteria
Inclusion Criteria:
- Patients with a clinical and imaging diagnosis of a vascular anomaly.
- No prior treatment for the vascular anomaly.
- Subjects undergoing clinically indicated sclerotherapy, embolization and/or
ablation.
- Male or female with age greater than or equal to 18 years.
- Capacity and willingness to provide a written informed consent..
Exclusion Criteria:
- Subjects with prior treatment for their vascular anomaly.
- Uncorrectable coagulopathy.
- Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours
of the procedure.
Filters
Vascular Malformations
Vascular Anomaly
Hemangioma
Arteriovenous Malformations
Venous Malformation
Klippel Trenaunay Syndrome
Lymphatic Malformation
NA
COMPLETED
ADULT
OLDER_ADULT