Transplant; Failure, KidneyNCT01883583
Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney
A study testing Contrast-enhanced Ultrasound And Sonoelastography in people with Transplant; Failure, Kidney, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Transplant; Failure, Kidney
- What is being tested?
- Contrast-enhanced Ultrasound And Sonoelastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1)Patients to perform ultrasound guided biopsy of transplanted kidney
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Jeong Yeon Cho, Professor, 82-2-2072-3074, radjycho@snu.ac.kr
Sang Youn Kim, Professor, 82-2-2072-3321, iwishluv@empas.com
About this study
Official title: Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney for Evaluation of Effectiveness of Perfusion Parameter in Assessment of Allograft Nephropathy
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
Read the 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.
- Conditions
- Transplant; Failure, Kidney
- Being tested
- Contrast-enhanced Ultrasound And Sonoelastography
- Keywords
- Ultrasound, Perfusion Imaging, Elasticity Imaging Techniques, Kidney Transplantation, Graft Rejection, Chronic allograft nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced Ultrasound And SonoelastographyDevice
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 group | Role | What they receive |
|---|---|---|
| Pilot group | Experimental | 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. Receives: Device: Contrast-enhanced Ultrasound And Sonoelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of time-intensity curve(TIC) using contrast-enhanced ultrasound
Measured: The day of admission (within 24hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant; Failure, KidneyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Yeon Cho, Seoul National University Hospital
- Investigators
- Jeong Yeon Cho, Professor, Principal investigator, Department of Radiology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883583
- Sponsor's protocol ID
- SeoulNUH-rad2
- Status last verified
- Nov 2013
- First submitted
- 15 Jun 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney for Evaluation of Effectiveness of Perfusion Parameter in Assessment of Allograft Nephropathy
- ClinicalTrials.gov ID
- NCT01883583
- Acronym / sponsor ID
- SeoulNUH-rad2
- Conditions
- Transplant; Failure, Kidney
- Keywords
- Ultrasound, Perfusion Imaging, Elasticity Imaging Techniques, Kidney Transplantation, Graft Rejection, Chronic allograft nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot group | Experimental | Device: Contrast-enhanced Ultrasound And SonoelastographyContrast-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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1)Patients to perform ultrasound guided biopsy of transplanted kidney
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced Ultrasound And SonoelastographyBefore 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. | Device | Pilot group |
Primary outcome
Acquisition of time-intensity curve(TIC) using contrast-enhanced ultrasound
Time frame: The day of admission (within 24hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Yeon Cho, Professor principal investigator
Department of Radiology, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced Ultrasound And Sonoelastography in people with Transplant; Failure, Kidney, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong Yeon Cho, Professor (82-2-2072-3074, radjycho@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquisition of time-intensity curve(TIC) using contrast-enhanced ultrasound (time frame: The day of admission (within 24hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.