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

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ClinicalTrials.gov Identifier: NCT01894607
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : March 15, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : December 2014

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Successful Capture of IO-CEUS Images [ Time Frame: 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) [ Time Frame: 1 day ]
    Number of participants that show better image quality in terms of lesion conspicuity and enhancement following contrast injection vs. baseline.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894607


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Ott Le, MD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01894607    
Other Study ID Numbers: 2012-0124
NCI-2013-02232 ( Registry Identifier: NCI CTRP )
First Posted: July 10, 2013    Key Record Dates
Results First Posted: March 15, 2016
Last Update Posted: April 14, 2016
Last Verified: March 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:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type