Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney

• ClinicalTrials.gov Identifier: NCT01883583
• Recruitment Status: Unknown
• First Posted: June 21, 2013
• Last Update Posted: November 6, 2013
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Jeong Yeon Cho, Seoul National University Hospital

Tracking Information

• First Submitted Date: June 15, 2013
• First Posted Date: June 21, 2013
• Last Update Posted Date: November 6, 2013
• Study Start Date: June 2013
• Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 20, 2013): Acquisition of time-intensity curve(TIC) using contrast-enhanced ultrasound [ Time Frame: The day of admission (within 24hours) ]
• Original Primary Outcome Measures (submitted: June 19, 2013): Acquisition of time-intensity curve(TIC) using contrast-enhanced ultrasound [ Time Frame: three day after approval of Institutional Review Board ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Transplant; Failure, Kidney

Intervention

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.

Study Arms

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.

Intervention: Device: Contrast-enhanced Ultrasound And Sonoelastography

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 19, 2013): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2015
• Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01883583
• Other Study ID Numbers: SeoulNUH-rad2
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jeong Yeon Cho, Seoul National University Hospital
• Study Sponsor: Seoul National University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jeong Yeon Cho, Professor; Department of Radiology, Seoul National University Hospital

• PRS Account: Seoul National University Hospital
• Verification Date: November 2013