Evaluating the Accuracy of Microvessel Ultrasound Imaging for Detecting Extent of Disease in Patients With Angiosarcoma of the Skin

Skin Angiosarcoma Clinical Trial

Official title:

Microvessel Ultrasound Imaging of Cutaneous Angiosarcoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05729425
• Other study ID #: 21-005183
• Secondary ID: NCI-2022-0960921
• Status: Terminated
• Start date: October 31, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the accuracy of a new ultrasound technology called microvessel imaging for detecting the extent of disease among patients with angiosarcoma of the skin. Microvessel ultrasound imaging uses high frequency waves to visualize vessels in the skin that are not easily seen using other imaging tests.

Description:

PRIMARY OBJECTIVE: I. To determine the accuracy of depicting extent of disease of cutaneous angiosarcoma before and after neoadjuvant treatment compared to clinical photographs, magnetic resonance imaging (MR) or positron emission tomography (PET)/computed tomography (CT) imaging and surgical pathology both on skin biopsies and surgical excision. OUTLINE: Patients undergo microvessel ultrasound imaging on study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Diagnosed with cutaneous angiosarcoma of the breast or scalp and scheduled for trimodality therapy
• Twenty one years of age or older

Exclusion Criteria:

• Unwilling to consent to microvessel ultrasound imaging
• Younger than 21 years of age

Related Conditions & MeSH terms

• Skin Angiosarcoma

Intervention

Device:
• Ultrasound Microvessel Imaging
Undergo microvessel ultrasound imaging

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	Accuracy of microvessel ultrasound imaging	Accuracy with respect to gold standard quantitative measures of disease extent and imaging-based measurements will be evaluated using Lin's concordance correlation coefficient along with 95% confidence intervals (CI's). These will be performed separately pre- and post-treatment. Pearson correlations and 95% CI's between imaging modality measurements will also be estimated to help guide future comparative analyses. Bland-Altman plots will also be generated to visualize agreement.	Through to study completion up to one year

External Links

•   Mayo Clinic Clinical Trials