Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney
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|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
|Condition or disease||Intervention/treatment||Phase|
|Transplant; Failure, Kidney||Device: Contrast-enhanced Ultrasound And Sonoelastography||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Acquisition of time-intensity curve(TIC) using contrast-enhanced ultrasound [ Time Frame: The day of admission (within 24hours) ]
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
|Contact: Jeong Yeon Cho, Professorfirstname.lastname@example.org|
|Contact: Sang Youn Kim, Professoremail@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Jeong Yeon Cho, Professor 82-2-2072-3074 firstname.lastname@example.org|
|Contact: Sang Youn Kim, Professor 82-2-2072-3321 email@example.com|
|Sub-Investigator: Sang Youn Kim, Professor|
|Sub-Investigator: JoongYub Lee, Professor|
|Principal Investigator:||Jeong Yeon Cho, Professor||Department of Radiology, Seoul National University Hospital|