Study Stopped
images obtained were non-diagnostic
Elastographic Imaging of Renal Transplants
Elastorenal
Pilot Study to Define Parameters of Elastography Compared to Color Flow Doppler Ultrasound in Renal Transplants
1 other identifier
interventional
10
1 country
1
Brief Summary
The study was developed to acquire images of normal, then abnormal, then unknown diagnosis for transplanted kidneys in order to determine whether the elastography imaging modality, a type of ultrasound imaging, can provide data useful for diagnosis of renal transplant abnormalities. The specific aims of this study are:
- 1.To define normal elastography imaging by correlation with clinical findings.
- 2.To define specific abnormal elastography images by correlation with clinical findings.
- 3.To determine whether elastography could be useful in early diagnosis of abnormalities of renal transplants, especially in early rejection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2006
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 9, 2009
CompletedJuly 9, 2009
July 1, 2009
3 years
May 8, 2009
July 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of features of a set of elastography images that can be characterized as those of a normally functioning transplanted kidney, or those of specific abnormalities
after up to 50 "normal" images are collected
Secondary Outcomes (1)
Assessment of the value of renal transplant imaging by elastography compared to standard ultrasound
by the time up to 100 images are obtained
Study Arms (3)
1
OTHERnormally functioning transplanted kidneys
2
OTHERtransplanted kidney undergoing known rejection or other known abnormality
3
OTHERtransplanted kidney with unknown diagnosis
Interventions
ultrasound imaging using a specialized computer that processes the data for tissue hardness
Eligibility Criteria
You may qualify if:
- Adult (over 18) male or female renal transplant patient
- normally functioning
- or being evaluated for a possible problem
You may not qualify if:
- unwilling or unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas health Science Center at Houston
Houston, Texas, 77030, United States
Related Publications (1)
Weitzel WF, Kim K, Rubin JM, Xie H, O'Donnell M. Renal advances in ultrasound elasticity imaging: measuring the compliance of arteries and kidneys in end-stage renal disease. Blood Purif. 2005;23(1):10-7. doi: 10.1159/000082005.
PMID: 15627731BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Alan M Cohen, MD
The University of Texas Health Science Center, Houston
- STUDY DIRECTOR
Jonathan Ophir, PhD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 8, 2009
First Posted
July 9, 2009
Study Start
June 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
July 9, 2009
Record last verified: 2009-07