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OpenTrials
Completed

NCT Number: NCT02789163

Comparison of Diagnostic Accuracy of Automated Volume Breast Scanner to Hand Held Ultrasound for Diagnostic Breast Exam

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

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Key information

Conditions

Breast Mass

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

breast ultrasound; hand held and automated volume breast scanner

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Northeastern Ohio Radiology Research and Education Fund

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 2, 2016
Registry last updated
Jun 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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