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

NCT ID: NCT05729425

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-31

Study Completion Date

2023-08-15

Brief Summary

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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

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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.

Conditions

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Skin Angiosarcoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (microvessel ultrasound imaging)

Patients undergo microvessel ultrasound imaging on study.

Ultrasound Microvessel Imaging

Intervention Type DEVICE

Undergo microvessel ultrasound imaging

Interventions

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Ultrasound Microvessel Imaging

Undergo microvessel ultrasound imaging

Intervention Type DEVICE

Other Intervention Names

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3D Ultrasound Microvessel Imaging UMI

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tiffany M Sae-Kho

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2022-09609

Identifier Type: REGISTRY

Identifier Source: secondary_id

21-005183

Identifier Type: OTHER

Identifier Source: secondary_id

21-005183

Identifier Type: -

Identifier Source: org_study_id

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