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Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01883583
Recruitment Status : Unknown
Verified November 2013 by Jeong Yeon Cho, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : June 21, 2013
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
Jeong Yeon Cho, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Transplant; Failure, Kidney Device: Contrast-enhanced Ultrasound And Sonoelastography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney for Evaluation of Effectiveness of Perfusion Parameter in Assessment of Allograft Nephropathy
Study Start Date : June 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Pilot group
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.
Device: Contrast-enhanced Ultrasound And Sonoelastography
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 Measures :
  1. Acquisition of time-intensity curve(TIC) using contrast-enhanced ultrasound [ Time Frame: The day of admission (within 24hours) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01883583


Contacts
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Contact: Jeong Yeon Cho, Professor 82-2-2072-3074 radjycho@snu.ac.kr
Contact: Sang Youn Kim, Professor 82-2-2072-3321 iwishluv@empas.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jeong Yeon Cho, Professor    82-2-2072-3074    radjycho@snu.ac.kr   
Contact: Sang Youn Kim, Professor    82-2-2072-3321    iwishluv@empas.com   
Sub-Investigator: Sang Youn Kim, Professor         
Sub-Investigator: JoongYub Lee, Professor         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jeong Yeon Cho, Professor Department of Radiology, Seoul National University Hospital
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Responsible Party: Jeong Yeon Cho, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01883583    
Other Study ID Numbers: SeoulNUH-rad2
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013
Keywords provided by Jeong Yeon Cho, Seoul National University Hospital:
Ultrasound
Perfusion Imaging
Elasticity Imaging Techniques
Kidney Transplantation
Graft Rejection
Chronic allograft nephropathy
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases