Elastographic Imaging of Renal Transplants

Renal Transplant Clinical Trial

— Elastorenal  

Official title:

Pilot Study to Define Parameters of Elastography Compared to Color Flow Doppler Ultrasound in Renal Transplants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00935727
• Other study ID #: HSC-MS-06-0255
• Status: Terminated
• Phase: Phase 1
• First received: May 8, 2009
• Last updated: July 7, 2009
• Start date: June 2006
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Renal Transplant

Intervention

Other:
• Elastographic imaging
ultrasound imaging using a specialized computer that processes the data for tissue hardness

Locations

Country	Name	City	State
United States	The University of Texas health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Memorial Hermann Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assessment of the value of renal transplant imaging by elastography compared to standard ultrasound		by the time up to 100 images are obtained	No