Breast DiseasesNCT02310776
Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound
A study testing Supine automated breast ultrasound scanner and High-resolution handheld breast ultrasound in people with Breast Diseases, run by Northwestern University at 2 sites in United States.
Trial summary
Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional handheld (HH) breast ultrasound (US) exam. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Diseases
- What is being tested?
- Supine automated breast ultrasound scanner and High-resolution handheld breast ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- anyone who is referred for an ultrasound of the breast
Who cannot join
- Subjects whose breast thickness is greater than 6 cm.The maximum depth of image filed for the ABVS acquisition is 6 cm
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Medicine
Chicago, Illinois, 60611
Weinstein Imaging
Pittsburgh, Pennsylvania, 15206
About this study
Official title: Breast Lesion Detection Using the Acuson S2000 Automated Breast Volume Scanner (ABVS) Compared With Handheld (HH) Physician-performed Ultrasound (US) Examinations
Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional handheld (HH) breast ultrasound (US) exam.
Read the detailed description
This is a research study to test a FDA-approved automated breast ultrasound (ABVS) machine in subjects recommended for an ultrasound of the breast. The main purpose of the study is to compare images obtained from the automated breast ultrasound exam with the standard physician performed handheld breast ultrasound exam for lesion detection equivalence.
Each subject will have a bilateral hand-held breast ultrasound and a bilateral automated breast ultrasound, both exams preferably done on the same day. The hand-held ultrasound will be performed by a breast imaging physician participating in the study and the automated ultrasound exam will be performed by a sonographer.
There is no radiation risk from ultrasound. The physician performing the handheld breast ultrasound is blinded to the study, will not know the subject's history, but only the reason for the breast ultrasound exam.
The automated scan requires gentle pressure on the breast during a scan. Three basic views will be acquired for each breast, each scan lasting approximately one minute. Once all necessary views are acquired, the images will be sent to a remote workstation, where a second radiologist, also blinded to the results of the handheld study, will interpret the automated ultrasound.
Once all images and patient information are gathered, the study radiologists will review the previous images, if available, to provide the final result that will determine clinical management. Therefore, it is possible that the hand-held or automated ultrasound scan will lead to further evaluation of the breast and possibly a biopsy.
- Conditions
- Breast Diseases
- Being tested
- Supine automated breast ultrasound scanner, High-resolution handheld breast ultrasound
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine automated breast ultrasound scannerDevice
Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.
High-resolution handheld breast ultrasoundDevice
Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist
| Study group | Role | What they receive |
|---|---|---|
| Automated & Handheld breast US exams | Other | 1. Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner.
2. Handheld breast ultrasound exam: High-resolution handheld breast ultrasound. Receives: Device: Supine automated breast ultrasound scanner; Device: High-resolution handheld breast ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US)
Solid lesions found on whole breast 3D supine automated breast ultrasound are compared in number and identity with solid lesions found using high resolution standard of care handheld breast ultrasound performed by physicians
Measured: Time for performance of ABVS was measured separately from interpretation time. Time for performance of real time HH whole breast US was also measured. For HH US physician performed, performance included interpretation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Principal investigator, Ellen Mendelson, Northwestern University
- Investigators
- Ellen B Mendelson, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310776
- Sponsor's protocol ID
- STU00043696
- Status last verified
- Jan 2016
- First submitted
- 25 Nov 2014
- Last updated
- 9 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Lesion Detection Using the Acuson S2000 Automated Breast Volume Scanner (ABVS) Compared With Handheld (HH) Physician-performed Ultrasound (US) Examinations
- ClinicalTrials.gov ID
- NCT02310776
- Acronym / sponsor ID
- STU00043696
- Conditions
- Breast Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Posted 8 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional handheld (HH) breast ultrasound (US) exam.
Detailed description
This is a research study to test a FDA-approved automated breast ultrasound (ABVS) machine in subjects recommended for an ultrasound of the breast. The main purpose of the study is to compare images obtained from the automated breast ultrasound exam with the standard physician performed handheld breast ultrasound exam for lesion detection equivalence.
Each subject will have a bilateral hand-held breast ultrasound and a bilateral automated breast ultrasound, both exams preferably done on the same day. The hand-held ultrasound will be performed by a breast imaging physician participating in the study and the automated ultrasound exam will be performed by a sonographer.
There is no radiation risk from ultrasound. The physician performing the handheld breast ultrasound is blinded to the study, will not know the subject's history, but only the reason for the breast ultrasound exam.
The automated scan requires gentle pressure on the breast during a scan. Three basic views will be acquired for each breast, each scan lasting approximately one minute. Once all necessary views are acquired, the images will be sent to a remote workstation, where a second radiologist, also blinded to the results of the handheld study, will interpret the automated ultrasound.
Once all images and patient information are gathered, the study radiologists will review the previous images, if available, to provide the final result that will determine clinical management. Therefore, it is possible that the hand-held or automated ultrasound scan will lead to further evaluation of the breast and possibly a biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Automated & Handheld breast US exams | Other | Device: Supine automated breast ultrasound scanner, Device: High-resolution handheld breast ultrasound1. Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner. 2. Handheld breast ultrasound exam: High-resolution handheld breast ultrasound. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- anyone who is referred for an ultrasound of the breast
Key exclusion criteria (1 listed)
- Subjects whose breast thickness is greater than 6 cm.The maximum depth of image filed for the ABVS acquisition is 6 cm
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 |
|---|---|---|
| Supine automated breast ultrasound scannerAutomated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist. | Device | Automated & Handheld breast US exams |
| High-resolution handheld breast ultrasoundStandard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist | Device | Automated & Handheld breast US exams |
Primary outcome
Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US)
Time frame: Time for performance of ABVS was measured separately from interpretation time. Time for performance of real time HH whole breast US was also measured. For HH US physician performed, performance included interpretation.
Solid lesions found on whole breast 3D supine automated breast ultrasound are compared in number and identity with solid lesions found using high resolution standard of care handheld breast ultrasound performed by physicians
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ellen B Mendelson, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine automated breast ultrasound scanner and High-resolution handheld breast ultrasound in people with Breast Diseases, run by Northwestern University at 2 sites 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 1 inclusion and 1 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 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 8 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US) (time frame: Time for performance of ABVS was measured separately from interpretation time. Time for performance of real time HH whole breast US was also measured. For HH US physician performed, performance included interpretation.). 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 9 Feb 2016.