Clinical trial · Observational
CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study
To Determine the Impact on Reader Performance, as Defined by the Area Under the Receiver Operating Characteristic Curve, When Automated Breast Ultrasound and a Screening Mammogram Are Combined, Compared to a Screening Mammogram Alone in Asymptomatic Women With >50% Parenchymal Density and a Screening Mammogram Assigned a BI-RADS Assessment Category 1 (Negative) or 2 (Normal With Benign Findings).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening mammography (XRM) are combined, compared to screening mammography alone in asymptomatic women with \>50% parenchymal density and a screening mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings). The effect of the improved Reader performance is illustrated by plotting the ROC curves for XRM alone and XRM+ABUS. If Reader performance improves with the addition of ABUS to the XRM, the area under the curve (AUC) for XRM+ABUS (AUCXRM+ABUS) will be greater than the area under the curve for XRM Alone (AUCXRM Alone). This difference is represented as ∆AUCABUS. The null and alternative hypotheses can be formally expressed as follows: H0: ∆AUCABUS = 0, AUCXRM+ABUS = AUCXRM Alone The null hypothesis is that Reader performance will be unchanged with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2. HA: ∆AUCABUS ≠ 0, AUCXRM+ABUS ≠ AUCXRM Alone The alternative hypothesis is that Reader performance will be changed with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2. A statistically significant change will be considered equivalent to a statistically significant improvement if the estimated value of AUCXRM+ABUS is greater than that of AUCXRM Alone with statistical significance at an alpha level of .05 for a two-sided test.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated Breast Ultrasound (ABUS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Asymptomatic Women who have Dense Breast Tissue
- description
- Women who have no signs or symptoms of breast cancer who have \> 50% parenchymal density on mammography.
- interventionNames
- Device: Automated Breast Ultrasound (ABUS)
Primary outcomes (1)
- measure
- Interpreting Physician Performance In Detecting Breast Cancer
- timeFrame
- Two months
- description
- To determine the impact on Interpreting Physician (Reader) Performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic (ROC) Curve (AUC), when ABUS and XRM are combined (XRM+ABUS), compared to XRM Alone in asymptomatic women with \>50% parenchymal density (BI-RADS Composition/Density rating of 3 or 4) and a screening mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).
Secondary outcomes (1)
- measure
- Interpreting Physician sensitivity and specificity of breast cancer detection.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Interpreting Physician as defined under 21CFR §900.12(a)(1)(i)(B)(2). * Fellowship-Trained in Breast Imaging and or have 10 years experience in breast imaging in which the radiologist's practice was at least 70% breast imaging * Currently meets the minimum Mammography Interpretation requirements per MQSA * Review Rate of at least 1,000 Mammograms annually for the year prior to study participation * Review Rate of at least 500 Breast Ultrasounds annually for the year prior to study participation * Successful completion of ABUS training Exclusion Criteria: * Does not meet definition of Interpreting Physician as defined under 21CFR §900.12(a)(1)(i)(B)(2). * Does not meet requirements of Fellowship-Trained in Breast Imaging and or have 10 years experience in breast imaging in which the radiologist's practice was at least 70% breast imaging * Does not meet requirements of minimum Mammography Interpretation requirements per MQSA * Does not meet requirements of Review Rate of at least 1,000 Mammograms annually for the year prior to study participation * Does not meet requirements of Review Rate of at least 500 Breast Ultrasounds annually for the year prior to study participation * Does not meet requirements of successful completion of ABUS training
References
Publications (0)
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