Clinical trial · Interventional
Comparison of Three Methods for Early Detection of Breast Cancer
Contrast Enhanced Ultrasound (CEUS) With US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer
NCT03954015CI-TRIAL-00055847completedEarly Phase 1ClinicalTrials.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)
Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).
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 |
|---|---|---|---|
| Proliferative Breast Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Enhanced imaging | Diagnostic Test | — | UNRESOLVED |
| Lumason | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- patients over age 30 with suspicious BIRADS 4/5 Lesions
- description
- Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.
- interventionNames
- Diagnostic Test: Contrast Enhanced imaging
- Drug: Lumason
Primary outcomes (4)
- measure
- CEUS true positive diagnosis
- timeFrame
- 1 year
- description
- The number of CEUS true positive diagnosis defined as suspicious enhancement/ mass corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
- measure
- CEUS false positive diagnosis
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Patients, greater than 30 years of age * In good general health as evidenced by medical history * BIRADS 4 or 5 suspicious breast lesions who are scheduled for breast biopsy. Exclusion Criteria: * Patients who are less than 30 years of age * Have known or suspected cardiac shunts * Have history of hypersensitive allergic reactions to any imaging contrast agents * Pregnant (a urine pregnancy test will be given at no cost to the patient) * Are nursing babies * Poor renal function * Are unwilling or unable (such as having a pacemaker) to undergo a CEMR
References
Publications (0)
Data not yet available
No reference posted for this study.