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

M.D. Anderson Cancer Center

Status

Withdrawn

Conditions

Breast Carcinoma

Treatments

Procedure: Ultrasonography

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05005936

2020-0831

NCI-2021-05381 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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