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OpenTrials
Completed

NCT Number: NCT01894607

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

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.

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Key information

Conditions

Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contrast Enhanced Intraoperative Ultrasound

Procedure

During standard of care surgery, radiologist will take images and videos with an ultrasound machine before and after patient given the contrast agent.

Definity

Drug

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.

phone call

Behavioral

Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
First posted
Jul 10, 2013
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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