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

Terminated

• Conditions: Skin Angiosarcoma
• Interventions: Device: Ultrasound Microvessel Imaging

• Registration Number: NCT05729425
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-10-31
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-15
• Status Verified: 2023-08
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (microvessel ultrasound imaging)	Ultrasound Microvessel Imaging	Patients undergo microvessel ultrasound imaging on study.

Primary Outcome Measures

Name	Time	Method
Accuracy of microvessel ultrasound imaging	Through to study completion up to one year	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States