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

M.D. Anderson Cancer Center

Overview

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.

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).

Study Type

OBSERVATIONAL

Conditions

Breast Carcinoma

Interventions

UltrasonographyPROCEDURE

Undergo ABUS

UltrasonographyPROCEDURE

Undergo WBUS

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.