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N/A N=11 Diagnostic

Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy

Kidney Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01894607 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Successful Capture of IO-CEUS Images — 10 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Contrast Enhanced Intraoperative Ultrasound (Procedure); DEFINITY (Drug); Phone Call (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
M.D. Anderson Cancer Center
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Successful Capture of IO-CEUS Images		 10 —
SECONDARY
Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)		 6 —

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.

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.
View full record on ClinicalTrials.gov →

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.

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