N/A
Completed N=21
Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients
Source: ClinicalTrials.gov NCT02321527 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique — 20 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique |
20 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older.
- Ipsilateral biopsy-proven invasive breast cancer <5 cm in maximal dimension by Ultrasound or Mammography.
- No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign subsequent FNA biopsy.
Exclusion Criteria
- Pregnant or nursing women
- Prior SLN dissection
- Neoadjuvant chemotherapy.
- Prior axillary lymph node surgery.
- Prior history of ipsilateral breast cancer.
- Known or suspected: Cardiac shunts
- Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin
- Known or suspected: hypersensitivity to a prior OPTISON administration
Data sourced from ClinicalTrials.gov (NCT02321527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.