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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04836884
Other study ID # 20-011265
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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