Clinical trial · Interventional
Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses
Characterizing Breast Masses Using an Integrative Framework of Machine Learning and Radiomics
- 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)
This clinical trial investigates the role of contrast enhanced ultrasound (CEUS) in identifying cystic breast masses as benign or malignant. Ultrasound is a diagnostic imaging test that uses sound waves to make pictures of the body without using radiation (x-rays). Ultrasounds are widely used to diagnose many diseases in the body. This trial may help researchers learn if using CEUS will help in determining whether or not an ultrasound guided biopsy is necessary.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-Enhanced Ultrasound | Procedure | — | UNRESOLVED |
| Perflutren Lipid Microspheres | Drug | — | UNRESOLVED |
| Sulfur Hexafluoride Lipid Microspheres | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (contrast agent, CEUS)
- description
- Patients receive a contrast tracer (Lumason or DEFINITY) IV and then undergo CEUS scan over 60-90 minutes.
- interventionNames
- Procedure: Contrast-Enhanced Ultrasound
- Drug: Perflutren Lipid Microspheres
- Drug: Sulfur Hexafluoride Lipid Microspheres
Primary outcomes (2)
- measure
- Radiomics-based ML-classifier framework
- timeFrame
- Up to 12 months
- description
- The performance of radiomics-based ML classifier framework will be compared to the performance of the TIC metrics. The joint performance of radiomics and TIC analysis will be compared to their individual performances. The classifier performance will be assessed using the area under curve (AUC). The Z-test will be used to compare the difference between the area under the curves 1) AUCboth versus (vs.) AUCradiomic 2) AUCboth vs. AUCTIC 3) AUCTIC vs. AUCradiomic.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed breast masses assigned as BIRADS 4a, 4b, 4c or 5 by conventional US and recommended for ultrasound guided biopsy * Age \>= 18 years * Female Exclusion Criteria: * Contraindications to microbubble contrast: Patients who have a known pulmonary hypertension and any known hypersensitivity to US contrast agent * Women with renal failure or insufficiency (only if patient is receiving CESM scan) * Women with Iodine contrast allergy (only if patient is receiving CESM scan) * Women with the largest side of the mass measuring ≤ 1 cm (only if patient is receiving CEUS scan) * Women who are pregnant, possibly pregnant, or lactating * Women currently undergoing neoadjuvant chemotherapy * Women \< 18 years of age * Patient ≤ 30 years (only if patient is receiving CESM scan) * Masses in the same breast that had prior lumpectomy for cancer * Women with cancer in the same breast will be excluded however, women with cancer in the contralateral breast will be eligible to participate in the study * Women with an allergy to perflutren (only if patient is receiving CEUS scan) * Prior history of biopsy for that specific lesion * Women with breast implants
References
Publications (0)
Data not yet available