Kidney Cancer
Conditions
Keywords
Kidney Cancer, Renal Mass, Open partial nephrectomy, Ultrasound-guided surgery, DEFINITY, Contrast agent, Phone call
Brief 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.
Detailed description
DEFINITY is a contrast agent that is used to create better quality ultrasound images. On the day before or the day of the standard of care surgery, women who are able to become pregnant must have a negative blood or urine pregnancy test. If it a blood pregnancy test is performed, a portion of blood will be used from routine blood draws that are collected as part of your standard of care surgery. During your standard of care surgery, the radiologist will take images and videos with an ultrasound machine before you are given the contrast agent. This is done to learn if cancer has spread around the kidney. You will then receive the DEFINITY by vein over about 1 minute. After you receive the injection of DEFINITY, the radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier. Length of Study: Your active participation in this study will be over after you have completed the follow-up visit. Follow-Up Phone Call: You will have a follow-up phone call 30 days after your standard of care surgery is complete to review any side effects you may be having. This call should take about 10 minutes to complete. This is an investigational study. DEFINITY is FDA approved and commercially available for use in contrast enhanced echocardiography. It is not FDA approved or commercially available for use in radiology. Up to 11 patients will take part in this study. All will be enrolled at MD Anderson.
Interventions
PROCEDUREContrast Enhanced Intraoperative Ultrasound
During standard of care surgery, radiologist will take images and videos with an ultrasound machine before and after patient given the contrast agent.
DRUGDEFINITY
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.
BEHAVIORALPhone Call
Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Capture of IO-CEUS Images | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS) | 1 day | Number of participants that show better image quality in terms of lesion conspicuity and enhancement following contrast injection vs. baseline. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: October 07, 2013 to May 23, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participants by arm
| Arm | Count |
|---|---|
| Contrast Enhanced Intraoperative Ultrasound During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 1 |
Baseline characteristics
| Characteristic | Contrast Enhanced Intraoperative Ultrasound |
|---|---|
| Age, Continuous | 52 years |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Successful Capture of IO-CEUS Images
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.
Time frame: 1 day
Population: 1 participant was ineligible.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contrast Enhanced Intraoperative Ultrasound | Successful Capture of IO-CEUS Images | 10 participants |
Secondary
Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)
Number of participants that show better image quality in terms of lesion conspicuity and enhancement following contrast injection vs. baseline.
Time frame: 1 day
Population: 1 participant was ineligible.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contrast Enhanced Intraoperative Ultrasound | Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS) | 6 participants |