Breast CarcinomaEarly Phase 1NCT04925817
3D Ultrasound Microvessel Imaging for Breast Masses
A Early Phase 1 study testing Electronic Health Record Review and Ultrasound Microvessel Imaging in people with Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Electronic Health Record Review and Ultrasound Microvessel Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 18 May 2023
- Phase
- Early Phase 1
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
- Lesion size of 3 mm or larger.
- Age 18 or greater.
Who cannot join
- Women with previous breast surgery or breast implant.
- Lacking the capacity to consent.
- Women who are pregnant or lactating.
- Women who are receiving cancer therapy such as chemotherapy or radiation therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.
Read the detailed description
PRIMARY OBJECTIVES:
- Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard.
OUTLINE:
Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.
- Conditions
- Breast Carcinoma
- Being tested
- Electronic Health Record Review, Ultrasound Microvessel Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Medical record reviewed
Ultrasound Microvessel ImagingProcedure or surgery
Also called 3D Ultrasound Microvessel Imaging, UMI
Undergo 3D ultrasound microvessel imaging
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (ultrasound microvessel imaging) | Experimental | Patients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed. Receives: Other: Electronic Health Record Review; Procedure: Ultrasound Microvessel Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound diagnostic accuracy using McNemar's test
Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test.
Measured: Up to 1 year
Ultrasound parameters sensitivity using McNemar's test
Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score.
Measured: Up to 1 year
Ultrasound parameters specificity using McNemar's test
Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better.
Measured: Up to 1 year
Ultrasound parameters positive predictive value using McNemar's test
Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Measured: Up to 1 year
Ultrasound parameters negative predictive value using McNemar's test
Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. .
Measured: Up to 1 year
Ultrasound parameters accuracy using McNemar's test
Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Measured: Up to 1 year
Ultrasound parameters calculated by McNemar's test
Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Measured: Up to 1 year
Ultrasound parameters vs. Breast Image Reporting using McNemar's test
Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start19 Aug 2021
- Primary completion18 May 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shigao Chen, Ph.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925817
- Sponsor's protocol ID
- 21-002713
- Other IDs
- NCI-2021-04853, P30CA015083, R03CA241020, 21-002713
- Status last verified
- Jun 2024
- First submitted
- 25 May 2021
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Ultrasound Microvessel Imaging for Breast Masses
- ClinicalTrials.gov ID
- NCT04925817
- Acronym / sponsor ID
- 21-002713
- Conditions
- Breast Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 14 Jun 2021 (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 early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.
Detailed description
PRIMARY OBJECTIVES:
- Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard.
OUTLINE:
Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (ultrasound microvessel imaging) | Experimental | Other: Electronic Health Record Review, Procedure: Ultrasound Microvessel ImagingPatients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
- Lesion size of 3 mm or larger.
- Age 18 or greater.
Key exclusion criteria (4 listed)
- Women with previous breast surgery or breast implant.
- Lacking the capacity to consent.
- Women who are pregnant or lactating.
- Women who are receiving cancer therapy such as chemotherapy or radiation therapy.
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 |
|---|---|---|
| Electronic Health Record ReviewMedical record reviewed | Other | Diagnostic (ultrasound microvessel imaging) |
| Ultrasound Microvessel ImagingAlso: 3D Ultrasound Microvessel Imaging, UMIUndergo 3D ultrasound microvessel imaging | Procedure or surgery | Diagnostic (ultrasound microvessel imaging) |
Primary outcome
Ultrasound diagnostic accuracy using McNemar's test
Time frame: Up to 1 year
Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test.
Ultrasound parameters sensitivity using McNemar's test
Time frame: Up to 1 year
Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score.
Ultrasound parameters specificity using McNemar's test
Time frame: Up to 1 year
Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters positive predictive value using McNemar's test
Time frame: Up to 1 year
Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters negative predictive value using McNemar's test
Time frame: Up to 1 year
Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. .
Ultrasound parameters accuracy using McNemar's test
Time frame: Up to 1 year
Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters calculated by McNemar's test
Time frame: Up to 1 year
Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters vs. Breast Image Reporting using McNemar's test
Time frame: Up to 1 year
Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- 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.
Shigao Chen, Ph.D. 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?
A Early Phase 1 study testing Electronic Health Record Review and Ultrasound Microvessel Imaging in people with Breast Carcinoma, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 7 Jun 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ultrasound diagnostic accuracy using McNemar's test (time frame: Up to 1 year). The study lists 8 primary outcomes in all. 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 7 Jun 2024.