Vascular Anomaly Pathology and Genomics Biopsy Study

Mayo Clinic

Status: Completed

Conditions: Klippel Trenaunay Syndrome; Arteriovenous Malformations; Vascular Malformations; Lymphatic Malformation; Venous Malformation; Hemangioma; Vascular Anomaly

Treatments: Procedure: Percutaneous Vascular Anomaly/Malformation Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04836884

20-011265

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Vascular anomaly/malformation biopsy

Experimental group

Description:

Subjects with a vascular anomaly will have a research percutaneous vascular anomaly/malformation biopsy completed at the time of the clinically indicated percutaneous sclerotherapy, embolization and/or ablation.

Treatment:

Procedure: Percutaneous Vascular Anomaly/Malformation Biopsy