N/A
Completed N=11
Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
Source: ClinicalTrials.gov NCT01894607 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Successful Capture of IO-CEUS Images — 10 participants
Summary
The goal of this clinical research is to learn how effective an ultrasound contrast agent, called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both kidneys.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Capture of IO-CEUS Images |
10 | — |
| SECONDARY Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS) |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have previous cross sectional imaging (CT or MRI) demonstrating renal mass or masses that is amenable to open partial nephrectomy.
- Patient is scheduled for intraoperative ultrasound guided open partial nephrectomy.
- Patient must sign informed consent, with risks and benefits of CEUS explained (see risks outlined on the following pages)
Exclusion Criteria
- Patients with known renal mass scheduled for total or laparoscopic partial nephrectomy.
- Patients who are hypersensitive to Definity (Perflutren Lipid Microsphere)
- Patients with known history of right-to-left, bidirectional or transient right-to-left cardiac shunts.
- Pediatric patients less than 18 years of age.
- Pregnant or nursing mothers.
Data sourced from ClinicalTrials.gov (NCT01894607). 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.