NCT05005936

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

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Ultrasonography	Undergo ABUS
PROCEDURE	Ultrasonography	Undergo WBUS

Timeline

• Start date: 2021-11-29
• Primary completion: 2021-11-29
• Completion: 2021-11-29
• First posted: 2021-08-16
• Last updated: 2022-05-27

Locations

1 site across 1 country: United States