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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vascular anomaly/malformation biopsy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Vascular Anomaly/Malformation Biopsy | Procedure | US-guided percutaneous vascular anomaly core needle biopsy of up to 10 cores using an 18-gauge co-axial core needle biopsy device at the time of clinically indicated sclerotherapy, embolization or ablation treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of core biopsy of vascular anomalies for clinical genomics studies | DNA and RNA will be extracted from the biopsy specimens, undergo qualitative/quantitative quality control assessment and be analyzed by whole genome sequencing (DNA) and RNA sequence analysis (RNA-seq) to determine the adequacy of vascular anomaly biopsy for vascular anomaly genomics characterization. | 18 months |
| Adequacy of core biopsy of vascular anomalies for clinical pathology evaluation | Tissue from the vascular anomaly biopsies will undergo histopathology and immunohistochemical staining to determine the adequacy of vascular anomaly core biopsy for clinical pathology characterization. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of vascular anomaly core biopsy | Number of participants with biopsy-related adverse events as assessed by CTCAE v4.0 | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Bendel, MD | Mayo Clinic | Principal Investigator |
| David A Woodrum, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D006391 | Hemangioma |
| D001165 | Arteriovenous Malformations |
| D007715 | Klippel-Trenaunay-Weber Syndrome |
| D044148 | Lymphatic Abnormalities |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014652 | Vascular Diseases |
| D000798 | Angiomatosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |