Clinical trial · Interventional
Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients
Comparison of Preoperative Automated Breast Ultrasound (ABUS) and Magnetic Resonance Imaging (MRI) in Newly Diagnosed Breast Cancer Patients
NCT02488187CI-TRIAL-00025540ABUSunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients.
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 |
|---|---|---|---|
| ABUS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- ABUS vs MRI (ultrasound when indicated)
- description
- To compare the overall sensitivity and specificity of ABUS versus MRI (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients.
- interventionNames
- Device: ABUS
- type
- OTHER
- label
- ABUS vs mammography (ultrasound when indicated)
- description
- To compare the sensitivity and specificity of ABUS versus mammography (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients when MRI is not performed.
- interventionNames
- Device: ABUS
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women (age 18-100) undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer * Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy. * Bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the MRI and ABUS. * If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and ABUS will performed at KUCC (Study Arm 1). * If a breast MRI is not performed, an ABUS exam without MRI will be performed (Study Arm 2). * The MRI and ABUS exam must be obtained within 2 weeks of each other. Exclusion Criteria: * Males * Pregnant women * Lactating women * Patients \< 18 and \> 100 years of age * Patients with breast implants
References
Publications (0)
Data not yet available
No reference posted for this study.