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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01894607
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Procedure: Contrast Enhanced Intraoperative Ultrasound; Drug: DEFINITY; Behavioral: Phone Call	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Feasibility Study of Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Dec 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Contrast Enhanced Intraoperative Ultrasound 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.

Procedure: Contrast 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.; Drug: DEFINITY; 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.; Behavioral: Phone Call; Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Ott Le, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Texas MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT01894607
• Other Study ID Numbers: 2012-0124; NCI-2013-02232
• First Posted: Jul 10, 2013
• Last Update Posted: Apr 14, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by M.D. Anderson Cancer Center: Kidney Cancer; Renal Mass; Open partial nephrectomy; Ultrasound-guided surgery; DEFINITY; Contrast agent; Phone call
• Additional relevant MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell

Study Results

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.

Arm/Group Title	Contrast Enhanced Intraoperative Ultrasound
Arm/Group Description	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.
Period Title: Overall Study
STARTED	11
COMPLETED	10
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Contrast Enhanced Intraoperative Ultrasound
Arm/Group Description	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.
Overall Participants	11
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	52
Sex: Female, Male (Count of Participants)
Female	5 45.5%
Male	6 54.5%
Region of Enrollment (participants) [Number]
United States	11 100%

Outcome Measures

1. Primary Outcome

Title	Successful Capture of IO-CEUS Images
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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

1 participant was ineligible.

Arm/Group Title	Contrast Enhanced Intraoperative Ultrasound
Arm/Group Description	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.
Measure Participants	10
Number [participants]	10 90.9%

2. Secondary Outcome

Title	Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)
Description	Number of participants that show better image quality in terms of lesion conspicuity and enhancement following contrast injection vs. baseline.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

1 participant was ineligible.

Arm/Group Title	Contrast Enhanced Intraoperative Ultrasound
Arm/Group Description	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.
Measure Participants	10
Number [participants]	6 54.5%

Adverse Events

Time Frame	Adverse Events (AEs) and Serious Adverse Events (SAEs) were evaluated after the administration of contrast agent through the end of follow-up visit, up to 30 days.
Arm/Group Title	Contrast Enhanced Intraoperative Ultrasound
Arm/Group Description	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.
All Cause Mortality
	Contrast Enhanced Intraoperative Ultrasound
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Contrast Enhanced Intraoperative Ultrasound
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Contrast Enhanced Intraoperative Ultrasound
	Affected / at Risk (%)	# Events
Total	0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.