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

NCT05729425 | Terminated DMC FDA Device

• 2 other identifiers: 21-005183NCI-2022-09609
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Angiosarcoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational (microvessel ultrasound imaging)

Patients undergo microvessel ultrasound imaging on study.

Device: Ultrasound Microvessel Imaging

Interventions

Ultrasound Microvessel Imaging DEVICE

Undergo microvessel ultrasound imaging

Also known as: 3D Ultrasound Microvessel Imaging, UMI

Observational (microvessel ultrasound imaging)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 21 with new diagnosis of cutaneous angiosarcoma of the breast or scalp.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Tiffany M Sae-Kho

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 15, 2023
• Study Start: October 31, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

US (1)