Skin AngiosarcomaNCT05729425
Evaluating the Accuracy of Microvessel Ultrasound Imaging for Detecting Extent of Disease in Patients With Angiosarcoma of the Skin
An observational study of Skin Angiosarcoma, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Skin Angiosarcoma
- What is being tested?
- Ultrasound Microvessel Imaging
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 21 with new diagnosis of cutaneous angiosarcoma of the breast or scalp.
Who may be able to join
- 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
Who cannot join
- Unwilling to consent to microvessel ultrasound imaging
- Younger than 21 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Microvessel Ultrasound Imaging of Cutaneous Angiosarcoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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
- Skin Angiosarcoma
- Being tested
- Ultrasound Microvessel Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Microvessel ImagingDevice
Also called 3D Ultrasound Microvessel Imaging, UMI
Undergo microvessel ultrasound imaging
| Study group | Role | What they receive |
|---|---|---|
| Observational (microvessel ultrasound imaging) | Patients undergo microvessel ultrasound imaging on study. Receives: Device: Ultrasound Microvessel Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through to study completion up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start31 Oct 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Why it stopped: Unable to recruit participants due to rare disease
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AngiosarcomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany M Sae-Kho, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729425
- Sponsor's protocol ID
- 21-005183
- Other IDs
- NCI-2022-09609, 21-005183
- Status last verified
- Aug 2023
- First submitted
- 8 Feb 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvessel Ultrasound Imaging of Cutaneous Angiosarcoma
- ClinicalTrials.gov ID
- NCT05729425
- Acronym / sponsor ID
- 21-005183
- Conditions
- Skin Angiosarcoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit participants due to rare disease
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVE:
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (microvessel ultrasound imaging) | – | Device: Ultrasound Microvessel ImagingPatients undergo microvessel ultrasound imaging on study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 21 with new diagnosis of cutaneous angiosarcoma of the breast or scalp.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling to consent to microvessel ultrasound imaging
- Younger than 21 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Microvessel ImagingAlso: 3D Ultrasound Microvessel Imaging, UMIUndergo microvessel ultrasound imaging | Device | Observational (microvessel ultrasound imaging) |
Primary outcome
Accuracy of microvessel ultrasound imaging
Time frame: 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.
Results and safety
The study was stopped early (reason given: Unable to recruit participants due to rare disease). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany M Sae-Kho principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Angiosarcoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit participants due to rare disease). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of microvessel ultrasound imaging (time frame: Through to study completion up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.