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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05729425
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Angiosarcoma	Procedure: Ultrasound Microvessel Imaging

Detailed Description

PRIMARY OBJECTIVE:

1. 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Microvessel Ultrasound Imaging of Cutaneous Angiosarcoma
• Actual Study Start Date: Oct 31, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Observational (microvessel ultrasound imaging) Patients undergo microvessel ultrasound imaging on study.	Procedure: Ultrasound Microvessel Imaging; Undergo microvessel ultrasound imaging; Other Names: 3D Ultrasound Microvessel Imaging UMI

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Tiffany M Sae-Kho, Mayo Clinic in Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05729425
• Other Study ID Numbers: 21-005183; NCI-2022-09609; 21-005183
• First Posted: Feb 15, 2023
• Last Update Posted: Feb 15, 2023
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Hemangiosarcoma

Study Results

No Results Posted as of Feb 15, 2023