Clinical trial · Observational
Cystic Breast Masses by Contrast Enhanced Ultrasound (CEUS)
Qualitative and Quantitative Analysis of Cystic Breast Masses by Contrast Enhanced Ultrasound: Is Biopsy Necessary?
- 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)
The overarching goal of the proposed research is to evaluate whether qualitative and quantitative parameters in real time contrast enhanced ultrasound (CEUS) can aid in assessing suspicious indeterminate cystic appearing breast masses and ultimately determine whether or not an ultrasound guided biopsy is necessary. The underlying hypothesis is that breast masses (given BIRADS 4) that lack enhancement on CEUS will have a benign histology obtained by ultrasound guided core biopsy and/or surgery. Then, in the future, these non-enhancing cystic lesions can be followed and do not need biopsy intervention.
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 |
|---|---|---|---|
| Definity | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Breast Mass 4a-cystic
- description
- Contrast Enhanced UltraSound (CEUS) exams will be performed on a ultrasound machine for the 4a-cystic breast masses recommended for biopsy. An intravenous line (IV) line will be inserted into the vein in the arm for the administration of the contrast agent, Definity (10 µL/kg) The patient will be asked to lie on a table for the 4DCT and unenhanced CT procedure and the images will be recorded. For the contrast enhanced ultrasound, the contrast agent will be injected into the IV line. The CEUS will be performed and the images will be recorded. The contrast agent may be administered two to three more times as needed. Scanning will then be repeated with 30 and 90 seconds delay after the IV contrast administration.
- interventionNames
- Drug: Definity
- label
- Breast Mass 4a- non cystic
- description
- Contrast Enhanced UltraSound (CEUS) exams will be performed on a ultrasound machine for the 4a-non cystic breast masses recommended for biopsy. An intravenous line (IV) line will be inserted into the vein in the arm for the administration of the contrast agent, Definity (10 µL/kg) The patient will be asked to lie on a table for the 4DCT and unenhanced CT procedure and the images will be recorded. For the contrast enhanced ultrasound, the contrast agent will be injected into the IV line. The CEUS will be performed and the images will be recorded. The contrast agent may be administered two to three more times as needed. Scanning will then be repeated with 30 and 90 seconds delay after the IV contrast administration..
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * \>18 years of age * recommended for an ultrasound guided biopsy due to breast mass detection Exclusion Criteria: * \< 18 years of age * prior history of breast cancer * prior history of biopsy for that specific lesion * any condition that would be a contraindication to the microbubble contrast agent used in CEUS such as pulmonary hypertension, 3cardiac shunts, and allergy to perflutren.
References
Publications (0)
Data not yet available