Clinical trial · Interventional
Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
Feasibility Study of Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
NCT01894607CI-TRIAL-00021731completedN/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 how effective an ultrasound contrast agent, called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both kidneys.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Enhanced Intraoperative Ultrasound | Procedure | — | UNRESOLVED |
| DEFINITY | Drug | — | UNRESOLVED |
| Phone Call | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast Enhanced Intraoperative Ultrasound
- description
- During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent. Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier. Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.
- interventionNames
- Procedure: Contrast Enhanced Intraoperative Ultrasound
- Drug: DEFINITY
- Behavioral: Phone Call
Primary outcomes (1)
- measure
- Successful Capture of IO-CEUS Images
- timeFrame
- 1 day
- description
- Primary objective is to determine feasibility of obtaining intraoperative (IO) contrast enhanced ultrasound (CEUS) images in participants undergoing open partial nephrectomy. Feasibility defined as the successful capture of IO-CEUS images in 8 out of 10 participants.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have previous cross sectional imaging (CT or MRI) demonstrating renal mass or masses that is amenable to open partial nephrectomy. 2. Patient is scheduled for intraoperative ultrasound guided open partial nephrectomy. 3. Patient must sign informed consent, with risks and benefits of CEUS explained (see risks outlined on the following pages) Exclusion Criteria: 1. Patients with known renal mass scheduled for total or laparoscopic partial nephrectomy. 2. Patients who are hypersensitive to Definity (Perflutren Lipid Microsphere) 3. Patients with known history of right-to-left, bidirectional or transient right-to-left cardiac shunts. 4. Pediatric patients less than 18 years of age. 5. Pregnant or nursing mothers.
References
Publications (0)
Data not yet available
No reference posted for this study.