Elastographic Imaging of Renal Transplants

Phase 1

Terminated

• Conditions: Renal Transplant
• Interventions: Other: Elastographic imaging

• Registration Number: NCT00935727
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

The study is collecting standard ultrasound and elastographic images of transplanted kidneys in order to perfect the imaging technique to get the best pictures, and to evaluate these images for characteristics that may be of diagnostic value.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2009-05-08
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-07
• Study First Submitted QC: 2009-07-07
• Last Update Submitted: 2009-07-07
• Study First Posted: 2009-07-09
• Last Update Posted: 2009-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult (over 18) male or female renal transplant patient
• normally functioning
• or being evaluated for a possible problem

Exclusion Criteria

• unwilling or unable to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Elastographic imaging	normally functioning transplanted kidneys
2	Elastographic imaging	transplanted kidney undergoing known rejection or other known abnormality
3	Elastographic imaging	transplanted kidney with unknown diagnosis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Assessment of the value of renal transplant imaging by elastography compared to standard ultrasound	by the time up to 100 images are obtained

Trial Locations

Locations (1)

The University of Texas health Science Center at Houston; 🇺🇸 Houston, Texas, United States