- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02789163
Comparison of Diagnostic Accuracy of Automated Volume Breast Scanner to Hand Held Ultrasound for Diagnostic Breast Exam
Study Overview
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Unable to give informed consent
- breast abnormality greater than one quadrant
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of sonographer and mammography technologist performing Automated volume breast scanner
Time Frame: 1 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 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard G Barr, MD, PhD, Northeastern Ohio Radiology Research and Education Fund
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AVBS DIAG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Mass
-
Kashani Social Security HospitalUnknownPalpable Breast MassIran, Islamic Republic of
-
University of MichiganNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedBreast Cancer | Mass Cystic | Benign MassUnited States
-
Samsung MedisonUniversity of RochesterUnknownBreast Cancer | Breast Lesions | Breast MassUnited States
-
Samsung Medical CenterCompletedPancreatic Mass | Peripancreatic MassKorea, Republic of
-
The First Affiliated Hospital of the Fourth Military...RecruitingBreast Cancer | Ultrasound Imaging | Mass Screening | Cancer Screening | AI (Artificial Intelligence)China
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Yonsei UniversityNot yet recruitingMediastinal MassKorea, Republic of
-
Raziel Therapeutics Ltd.CompletedFlank MassUnited States
-
QT Ultrasound LLCCompletedMass LesionUnited States
-
Far Eastern Memorial HospitalUnknown
Clinical Trials on Ultrasound
-
Ahram Canadian UniversityCompletedCarpal Tunnel Syndrome | Median Neuropathy, Carpal TunnelEgypt
-
Eskisehir Osmangazi UniversityCompletedCarpal Tunnel Syndrome
-
Cairo UniversityUnknown
-
Ohio State University Comprehensive Cancer CenterWithdrawn
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Withdrawn
-
Mayo ClinicNational Cancer Institute (NCI); National Institute for Biomedical Imaging...RecruitingBreast CarcinomaUnited States
-
Bursa Yüksek İhtisas Education and Research HospitalNot yet recruitingShoulder Impingement Syndrome | Shoulder Pain
-
John PelleritoGeneral ElectricActive, not recruiting
-
Oregon Health and Science UniversityRecruiting
-
Yale UniversityCompletedPneumonia | Pulmonary Edema | DyspneaUnited States