Comparing the Performance of Automated Breast Ultrasonography to Hand-Held Whole Breast Ultrasonography in Breast Cancer Treatment Response Assessment

Study Overview
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Brief Summary
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This study compares the performance of automated breast ultrasonography and conventional hand-held whole breast ultrasonography when checking for response to breast cancer treatment. Breast ultrasonography is operator dependent and time-intensive. Automated breast ultrasonography scanners were developed to allow standardization of ultrasound scanning and scanning to be performed by any technologist, with or without previous ultrasound experience, without physician involvement. This study may validate the use of the automated breast ultrasonography.

Detailed Description
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PRIMARY OBJECTIVE: I. To estimate and compare the accuracy of automated breast ultrasonography (ABUS) and hand-held whole breast ultrasonography (WBUS) in predicting pathology complete response (pCR) with relative tumor volume change, using the receiver operating characteristic (ROC) curve analysis. SECONDARY OBJECTIVES: I. To evaluate the reproducibility of tumor volume measurements obtained by ABUS and handheld WBUS, respectively, using data collected at baseline for initial staging. II. To assess the agreement in relative tumor volume change (RC) (end-of-treatment versus [vs.] pre-treatment) between ABUS and WBUS. III. To estimate and compare the following diagnostic measures for ABUS and WBUS: sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). OUTLINE: Patients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment).

Official Title
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Comparing the Performance of Automated Breast Ultrasonography (ABUS) to Hand-Held Breast Ultrasonography (WBUS) in Breast Cancer Treatment Response Assessment in a Tertiary Cancer Center: A Prospective Study

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Procedure: Ultrasonography
* Procedure: Ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects to be studied will include patients seen in MD Anderson Breast imaging clinic at the Texas Medical Center (TMC) With breast cancer or suspicion of breast cancer Male or female who is older than 18 years of age Of any race Who consent to obtain technologist performed breast ultrasound and automated breast ultrasound English and non-English speakers (with language interpreter to assist in translation for non-English speakers) Exclusion Criteria: Patient who is less than 18 years of age Imaging obtained outside of MD Anderson TMC Surgery pathology from outside of MD Anderson will be excluded from this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative (ABUS, WBUS)<br>Patients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment). | Procedure: Ultrasonography<br>* Undergo ABUS<br>* Other names: US;Procedure: Ultrasonography<br>* Undergo WBUS<br>* Other names: US;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver operating characteristic (ROC) curve | Will compute relative tumor volume change for both automated breast ultrasonography (ABUS) and hand-held whole breast ultrasonography (WBUS) and estimate pathology complete response ROC curves for each. Will estimate the areas under the ROC curves along with 95% confidence intervals and then compare the values statistically. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor volume | Will compute the intraclass correlation coefficient for each method along with 95% confidence intervals and then compare these estimates. | through study completion, an average of 1 year | 
| Relative tumor volume change | Will compute the relative change in tumor volume for ABUS and WBUS and assess their agreement using the Bland-Altman approach. | through study completion, an average of 1 year | 
| Sensitivity | The cutoff point will be determined using Youden Index, i.e., the point that maximize (sensitivity specificity). | through study completion, an average of 1 year | 
| Specificity | The cutoff point will be determined using Youden Index, i.e., the point that maximize (sensitivity specificity). | through study completion, an average of 1 year | 
| Positive predictive value |  | through study completion, an average of 1 year | 
| Negative predictive value |  | through study completion, an average of 1 year |