Clinical trial · Interventional
Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients
Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Ultrasound Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients
NCT02321527CI-TRIAL-00028189completedN/AResults postedClinicalTrials.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)
The goal of this clinical research is to learn if an ultrasound contrast agent called OPTISON (perflutren protein type A) is effective in finding sentinel lymph nodes before surgery. Contrast agents can help make ultrasound images more accurate. The sentinel lymph node is the first node that may be the target of cancer cells that spread from the tumor.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy + Radioactive Seed Placement | Procedure | — | UNRESOLVED |
| Contrast-Enhanced Ultrasound (CEUS) | Device | — | UNRESOLVED |
| Perflutren Protein-Type A Microspheres Injectable Suspension | Drug | — | UNRESOLVED |
| Phone Call | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perflutren Protein-Type A Microspheres Injectable Suspension
- description
- Participants receive a subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension (OPTISON™). Ultrasound images and videos of tumor and lymph nodes in underarm area taken. Biopsy of sentinel lymph node that was identified in ultrasound performed, and a titanium clip marker inserted into the node. After biopsy, a radioactive seed may be inserted into the node to allow surgeon to find and remove it during surgery. Participant called by phone 30 days after seed is removed to check for any side effects. This phone call should take about 10 minutes.
- interventionNames
- Drug: Perflutren Protein-Type A Microspheres Injectable Suspension
- Device: Contrast-Enhanced Ultrasound (CEUS)
- Procedure: Biopsy + Radioactive Seed Placement
- Behavioral: Phone Call
Primary outcomes (1)
- measure
- Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique
- timeFrame
- 1 day
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years or older. 2. Ipsilateral biopsy-proven invasive breast cancer \<5 cm in maximal dimension by Ultrasound or Mammography. 3. No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign subsequent FNA biopsy. Exclusion Criteria: 1. Pregnant or nursing women 2. Prior SLN dissection 3. Neoadjuvant chemotherapy. 4. Prior axillary lymph node surgery. 5. Prior history of ipsilateral breast cancer. 6. Known or suspected: Cardiac shunts 7. Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin 8. Known or suspected: hypersensitivity to a prior OPTISON administration
References
Publications (0)
Data not yet available
No reference posted for this study.