Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney

Status Recruiting

Clinical Trial Summary

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01883583
Study type	Interventional
Source	Seoul National University Hospital
Contact	Jeong Yeon Cho, Professor
Phone	82-2-2072-3074
Email	radjycho@snu.ac.kr
Status	Recruiting
Phase	N/A
Start date	June 2013
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT00856895` - Quality of Life in Pre and Post Renal Transplant in Hispanic and Non-Hispanic Recipients
Completed	`NCT01680861` - Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium	Phase 3
Terminated	`NCT01679184` - XM-One Study for Living Donor Program	N/A
Completed	`NCT01642225` - Desensitization Protocol for Deceased Donor List	N/A
Completed	`NCT01709097` - Compliance/Adherence After Kidney Transplant, With or With Out Med-O-Wheel™.	N/A
Completed	`NCT02213068` - Belatacept 3 Month Post Transplant Conversion Study	Phase 4
Recruiting	`NCT01631058` - Renal Transplantation in the Elderly - nEverOld Study	Phase 4
Terminated	`NCT01163799` - A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients	Phase 1
Completed	`NCT01913392` - Effect of Laparoscopic Sleeve Gastrectomy in the Morbidly Obese, Kidney Transplant Candidate
Completed	`NCT01044303` - Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study)	Phase 4
Completed	`NCT00587158` - Oral Paricalcitol in Kidney Transplant Recipients	N/A
Terminated	`NCT01441570` - The Impact of Nebivolol Versus Metoprolol on Quality of Life	N/A
Completed	`NCT01172418` - Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols	Phase 4
Completed	`NCT02559297` - Effects of Sevoflurane and Desflurane on Treg	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.