NCT01894607

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 15, 2016

Completed
Last Updated

April 14, 2016

Status Verified

March 1, 2016

Enrollment Period

1.2 years

First QC Date

July 3, 2013

Results QC Date

February 17, 2016

Last Update Submit

March 15, 2016

Conditions

Kidney Cancer

Keywords

Kidney CancerRenal MassOpen partial nephrectomyUltrasound-guided surgeryDEFINITYContrast agentPhone call

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)

    1 day

Study Arms (1)

Contrast Enhanced Intraoperative Ultrasound

EXPERIMENTAL

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 UltrasoundDrug: DEFINITYBehavioral: Phone Call

Interventions

Contrast Enhanced Intraoperative UltrasoundPROCEDURE

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

Contrast Enhanced Intraoperative Ultrasound
DEFINITYDRUG

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.

Contrast Enhanced Intraoperative Ultrasound
Phone CallBEHAVIORAL

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

Contrast Enhanced Intraoperative Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Ott Le, MD/Associate Professor, Diagnostic Radiation Body Imaging
Organization
University of Texas (UT) MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org

Study Officials

  • Ott Le, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 10, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Last Updated

April 14, 2016

Results First Posted

March 15, 2016

Record last verified: 2016-03

Locations

US(1)