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Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney

Primary Purpose

Transplant; Failure, Kidney

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Contrast-enhanced Ultrasound And Sonoelastography
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transplant; Failure, Kidney focused on measuring Ultrasound, Perfusion Imaging, Elasticity Imaging Techniques, Kidney Transplantation, Graft Rejection, Chronic allograft nephropathy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1)Patients to perform ultrasound guided biopsy of transplanted kidney

Exclusion Criteria:

  • 1)Patients to have the medical histories of heart such as acute failure, arrhythmia, ischemia, infarction and angioplasty 2)Patients to show poor graft function which does not recovery within three days after transplantation

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot group

Arm Description

Contrast-enhanced Ultrasound And Sonoelastography of transplanted kidney will be performed for acquisition of a number of parameters and time-intensity curves, before ultrasound guided biopsy of transplanted kidney.

Outcomes

Primary Outcome Measures

Acquisition of time-intensity curve(TIC) using contrast-enhanced ultrasound

Secondary Outcome Measures

Full Information

First Posted
June 15, 2013
Last Updated
November 5, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01883583
Brief Title
Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney
Official Title
Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney for Evaluation of Effectiveness of Perfusion Parameter in Assessment of Allograft Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with pathologic results from ultrasound guided biopsy of transplanted kidney
Detailed Description
To check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with pathologic results from ultrasound guided biopsy of transplanted kidney. Ten patients scheduled to perform ultrasound guided biopsy of transplanted kidney will be enrolled. The patients who have previous medical history of cardiac problem or who do not recover renal function over three days after graft surgery will be excluded. Before ultrasound guided biopsy of transplanted kidney, we will perform conventional, Sonoelastography and real-time contrast-enhanced ultrasound using Sonovue for acquisition of parameters and data, respectively. We will check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images using analyzing program (VueBox, Bracco, Swiss). And we will verify the correlation of acquired data and parameters with pathologic results from ultrasound guided biopsy of transplanted kidney. From perfusion images, several regions of interest (ROIs) will be marked including main renal artery, segmental artery and renal medulla. A number of time-intensity curves (TICs) are acquired from ROIs using VueBox. The parameters acquired from time intensity curve (TIC) (i.e. arrival time, mean transit time, time to peak, basal intensity, peak intensity, area under curve, slope rate of ascending and descending curves), the date acquired from spectral Doppler ultrasound (i.e. restive index, pulsatility index) and Values of shear wave velocities of the several regions of interest acquired from Sonoelastography will be analyzed to find statistical significance in assessment of allograft nephropathy such as acute rejection or chronic allograft nephropathy. Pathologic conditions such as acute rejection may show the decrease in arrival time, peak intensity, area under curve suggesting total blood flow and accelerating slope rate, compared with non-pathologic condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplant; Failure, Kidney
Keywords
Ultrasound, Perfusion Imaging, Elasticity Imaging Techniques, Kidney Transplantation, Graft Rejection, Chronic allograft nephropathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilot group
Arm Type
Experimental
Arm Description
Contrast-enhanced Ultrasound And Sonoelastography of transplanted kidney will be performed for acquisition of a number of parameters and time-intensity curves, before ultrasound guided biopsy of transplanted kidney.
Intervention Type
Device
Intervention Name(s)
Contrast-enhanced Ultrasound And Sonoelastography
Intervention Description
Before ultrasound guided biopsy of transplanted kidney, we will perform conventional, Sonoelastography and real-time contrast-enhanced ultrasound using Sonovue for acquisition of parameters and data, respectively.
Primary Outcome Measure Information:
Title
Acquisition of time-intensity curve(TIC) using contrast-enhanced ultrasound
Time Frame
The day of admission (within 24hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1)Patients to perform ultrasound guided biopsy of transplanted kidney Exclusion Criteria: 1)Patients to have the medical histories of heart such as acute failure, arrhythmia, ischemia, infarction and angioplasty 2)Patients to show poor graft function which does not recovery within three days after transplantation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Yeon Cho, Professor
Phone
82-2-2072-3074
Email
radjycho@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Youn Kim, Professor
Phone
82-2-2072-3321
Email
iwishluv@empas.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Yeon Cho, Professor
Organizational Affiliation
Department of Radiology, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Yeon Cho, Professor
Phone
82-2-2072-3074
Email
radjycho@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Sang Youn Kim, Professor
Phone
82-2-2072-3321
Email
iwishluv@empas.com
First Name & Middle Initial & Last Name & Degree
Sang Youn Kim, Professor
First Name & Middle Initial & Last Name & Degree
JoongYub Lee, Professor

12. IPD Sharing Statement

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Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney

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