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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05005936
• Other study ID #: 2020-0831
• Secondary ID: NCI-2021-0538120
• Status: Withdrawn
• Start date: November 29, 2021
• Est. completion date: November 29, 2021

Study information

• Verified date: May 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Procedure:
• Ultrasonography
Undergo ABUS
• Ultrasonography
Undergo WBUS

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   MD Anderson Cancer Center