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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- M.D. Anderson Cancer Center
- Locations
- 1
- Primary Endpoint
- Area under the receiver operating characteristic (ROC) curve
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Area under the receiver operating characteristic (ROC) curve
Time Frame: 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 Outcomes
- Relative tumor volume change(through study completion, an average of 1 year)
- Tumor volume(through study completion, an average of 1 year)
- Sensitivity(through study completion, an average of 1 year)
- 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)