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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05729425
Other study ID # 21-005183
Secondary ID NCI-2022-0960921
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04339738 - Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma Phase 2

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