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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-05381 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0831 | Other Identifier | M D Anderson Cancer Center |
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No participants Enrolled
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancillary-Correlative (ABUS, WBUS) | Patients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonography | Procedure | Undergo ABUS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Relative tumor volume change |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with breast cancer or suspicion of breast cancer seen in MD Anderson Breast imaging clinic at the Texas Medical Center (TMC)
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| Name | Affiliation | Role |
|---|---|---|
| Monica L Huang | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Ultrasonography | Procedure | Undergo WBUS |
|
|
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 |
| 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 |
| 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 |
| Positive predictive value | through study completion, an average of 1 year |
| Negative predictive value | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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