Clinical trial NCT05005936: Comparing the Performance of Automated Breast Ultrasonography to Hand-Held Whole Breast Ultrasonography in Breast Cancer Treatment Response Assessment
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer or suspicion of breast cancer seen in MD Anderson Breast imaging clinic at the Texas Medical Center (TMC)

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).

Eligibility criteria: 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

Primary outcomes:
measure: Area under the receiver operating characteristic (ROC) curve
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Tumor volume
timeFrame: through study completion, an average of 1 year
measure: Relative tumor volume change
timeFrame: through study completion, an average of 1 year
measure: Sensitivity
timeFrame: through study completion, an average of 1 year
measure: Specificity
timeFrame: through study completion, an average of 1 year
measure: Positive predictive value
timeFrame: through study completion, an average of 1 year
measure: Negative predictive value
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Monica L Huang
role: PRINCIPAL_INVESTIGATOR
References: