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

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Brief 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (ABUS, WBUS)	Ultrasonography	Patients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment).

Primary Outcome Measures

Name	Time	Method
Area under the receiver operating characteristic (ROC) curve	through study completion, an average of 1 year	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.

Secondary Outcome Measures

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

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