An observational study in Skin Angiosarcoma, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-08-18.
Sponsored by Mayo Clinic · Observational
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.
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.
99 studies on the registry are indexed under Hemangiosarcoma; 16 are open to participants now.
Browse Hemangiosarcoma studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients over the age of 21 with new diagnosis of cutaneous angiosarcoma of the breast or scalp.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo microvessel ultrasound imaging on study.
Device: Ultrasound Microvessel Imaging
Undergo microvessel ultrasound imaging
Also known as: 3D Ultrasound Microvessel Imaging, UMI
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.
Time frame: Through to study completion up to one year
Ran from Oct 2022 to primary completion in Aug 2023, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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