Breast MassNCT02789163
Comparison of Diagnostic Accuracy of Automated Volume Breast Scanner to Hand Held Ultrasound for Diagnostic Breast Exam
An observational study of Breast Mass, run by Northeastern Ohio Radiology Research and Education Fund.
Trial summary
Women age >18 scheduled for a diagnostic ultrasound examination had both a hand held ultrasound and an automated breast volume scan. Exams were performed by different technologists. Images were blinded and blinded read for diagnostic accuracy of the two examinations Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Mass
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Aug 2013
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study.
Who may be able to join
- Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study.
Who cannot join
- Unable to give informed consent
- breast abnormality greater than one quadrant
About this study
Women age >18 scheduled for a diagnostic ultrasound examination had both a hand held ultrasound and an automated breast volume scan. Exams were performed by different technologists. Images were blinded and blinded read for diagnostic accuracy of the two examinations
Read the detailed description
Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study. If the patient had both a palpable mass and a mammogram that had an abnormality the indication was listed as a palpable abnormality. Exclusion criteria included inability to give informed consent and abnormality of the breast that is larger than one quadrant. No patients were excluded from the study.
All patients received both a Hand Held (HH) and Automated Breast Volume Scanner (ABVS) ultrasound. Patients were initially randomized to have either a HH or an ABVS. The HH ultrasound was performed by one of 4 sonographers that had a minimum of 10 years experience in breast ultrasound. A different sonographer than the one performing the HH or mammography technician performed ABVS. All technologists performing ABVS participated in a training course on ABVS and performed at least 10 patients satisfactorily before beginning the study. The choice of a mammography technician or sonography to perform the ABVS was randomized. Both the sonographer performing the HH and the sonographer or mammography technologist performing the ABVS were provided the patient's history and results of the mammogram if performed for placement of the ABVS and region of interest for the HH. However the results of the HH or ABVS were not available to the person performing the second examination.
Final diagnosis was performed either by a 12 gauge core biopsy (Celero, Hologic, Marlborough, MA ) or confirmation of a benign lesion by no significant change over 2 years.
- Conditions
- Breast Mass
- Being tested
- Ultrasound
- Keywords
- breast, ultrasound, diagnostic exam, automated volume breast scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
breast ultrasound; hand held and automated volume breast scanner
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
Diagnostic performance assuming BI-RADS category 1, 2, and 3 were benign and BI-RADS category 4 and 5 were malignant and using biopsy or clinical stability for two years as gold standard was assessed through ROC curves analysis. Sensitivity, specificity, Area Under the Curve (AUC) are presented along with 95% CI. Pairwise comparison of AUC between readers and methodologies are also given using z-statistics (6). P<0.05 was considered statistically significant. All tests were two-sided.
Measured: one day
Secondary outcomes (1)
Comparison of sonographer and mammography technologist performing Automated volume breast scanner
Diagnostic performance assuming BI-RADS category 1, 2, and 3 were benign and BI-RADS category 4 and 5 were malignant and using biopsy or clinical stability for two years as gold standard was assessed through ROC curves analysis. Sensitivity, specificity, Area Under the Curve (AUC) are presented along with 95% CI. Pairwise comparison of AUC between readers and methodologies are also given using z-statistics (6). P<0.05 was considered statistically significant. All tests were two-sided.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast MassStudies of the same condition, open and under way.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern Ohio Radiology Research and Education Fund
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard G. Barr MD, PhD, Northeastern Ohio Radiology Research and Education Fund
- Investigators
- Richard G Barr, MD, PhD, Principal investigator, Northeastern Ohio Radiology Research and Education Fund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789163
- Sponsor's protocol ID
- AVBS DIAG
- Status last verified
- May 2016
- First submitted
- 25 May 2016
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diagnostic Accuracy of Automated Volume Breast Scanner to Hand Held Ultrasound for Diagnostic Breast Exam
- ClinicalTrials.gov ID
- NCT02789163
- Acronym / sponsor ID
- AVBS DIAG
- Conditions
- Breast Mass
- Keywords
- breast, ultrasound, diagnostic exam, automated volume breast scanner
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Northeastern Ohio Radiology Research and Education FundUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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.
Women age >18 scheduled for a diagnostic ultrasound examination had both a hand held ultrasound and an automated breast volume scan. Exams were performed by different technologists. Images were blinded and blinded read for diagnostic accuracy of the two examinations
Detailed description
Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study. If the patient had both a palpable mass and a mammogram that had an abnormality the indication was listed as a palpable abnormality. Exclusion criteria included inability to give informed consent and abnormality of the breast that is larger than one quadrant. No patients were excluded from the study.
All patients received both a Hand Held (HH) and Automated Breast Volume Scanner (ABVS) ultrasound. Patients were initially randomized to have either a HH or an ABVS. The HH ultrasound was performed by one of 4 sonographers that had a minimum of 10 years experience in breast ultrasound. A different sonographer than the one performing the HH or mammography technician performed ABVS. All technologists performing ABVS participated in a training course on ABVS and performed at least 10 patients satisfactorily before beginning the study. The choice of a mammography technician or sonography to perform the ABVS was randomized. Both the sonographer performing the HH and the sonographer or mammography technologist performing the ABVS were provided the patient's history and results of the mammogram if performed for placement of the ABVS and region of interest for the HH. However the results of the HH or ABVS were not available to the person performing the second examination.
Final diagnosis was performed either by a 12 gauge core biopsy (Celero, Hologic, Marlborough, MA ) or confirmation of a benign lesion by no significant change over 2 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study.
Key inclusion criteria (1 listed)
- Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to participate in the study.
Key exclusion criteria (2 listed)
- Unable to give informed consent
- breast abnormality greater than one quadrant
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 |
|---|---|---|
| Ultrasoundbreast ultrasound; hand held and automated volume breast scanner | Device | – |
Primary outcome
Diagnostic Accuracy
Time frame: one day
Diagnostic performance assuming BI-RADS category 1, 2, and 3 were benign and BI-RADS category 4 and 5 were malignant and using biopsy or clinical stability for two years as gold standard was assessed through ROC curves analysis. Sensitivity, specificity, Area Under the Curve (AUC) are presented along with 95% CI. Pairwise comparison of AUC between readers and methodologies are also given using z-statistics (6). P<0.05 was considered statistically significant. All tests were two-sided.
1 secondary outcome
Comparison of sonographer and mammography technologist performing Automated volume breast scanner
Time frame: 1 day
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 2 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Richard G Barr, MD, PhD principal investigator
Northeastern Ohio Radiology Research and Education Fund
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Mass, run by Northeastern Ohio Radiology Research and Education Fund.
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 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: finished, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Diagnostic Accuracy (time frame: one day). 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 2 Jun 2016.