Vascular Anomaly Pathology and Genomics Biopsy Study

Arteriovenous Malformations Clinical Trial

Official title:

Validation of Core Biopsy of Vascular Anomalies for Clinical Pathology and Genomics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836884
• Other study ID #: 20-011265
• Status: Completed
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Klippel Trenaunay Syndrome
• Lymphangioma
• Lymphatic Abnormalities
• Lymphatic Malformation
• Vascular Anomaly
• Vascular Malformations
• Venous Malformation

Intervention

Procedure:
• Percutaneous Vascular Anomaly/Malformation Biopsy
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Safety of vascular anomaly core biopsy	Number of participants with biopsy-related adverse events as assessed by CTCAE v4.0	30 days

External Links

•   Mayo Clinic Clinical Trials