Clinical trial · Observational
Comparing the Performance of Automated Breast Ultrasonography to Hand-Held Whole Breast Ultrasonography in Breast Cancer Treatment Response Assessment
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants Enrolled
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasonography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (ABUS, WBUS)
- description
- Patients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment).
- interventionNames
- Procedure: Ultrasonography
Primary outcomes (1)
- measure
- Area under the receiver operating characteristic (ROC) curve
- timeFrame
- through study completion, an average of 1 year
- description
- 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 (6)
- measure
- Tumor volume
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available