Elastorenal: Elastographic Imaging of Renal Transplants

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Terminated

CT.gov ID

NCT00935727

Collaborator

Memorial Hermann Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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:

To define normal elastography imaging by correlation with clinical findings.
To define specific abnormal elastography images by correlation with clinical findings.
To determine whether elastography could be useful in early diagnosis of abnormalities of renal transplants, especially in early rejection.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplant	Other: Elastographic imaging	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 normally functioning transplanted kidneys	Other: Elastographic imaging ultrasound imaging using a specialized computer that processes the data for tissue hardness
Other: 2 transplanted kidney undergoing known rejection or other known abnormality	Other: Elastographic imaging ultrasound imaging using a specialized computer that processes the data for tissue hardness
Other: 3 transplanted kidney with unknown diagnosis	Other: Elastographic imaging ultrasound imaging using a specialized computer that processes the data for tissue hardness

Arm

Intervention/Treatment

Other: 1

normally functioning transplanted kidneys

Other: Elastographic imaging

ultrasound imaging using a specialized computer that processes the data for tissue hardness

Other: 2

transplanted kidney undergoing known rejection or other known abnormality

Other: Elastographic imaging

ultrasound imaging using a specialized computer that processes the data for tissue hardness

Other: 3

transplanted kidney with unknown diagnosis

Other: Elastographic imaging

ultrasound imaging using a specialized computer that processes the data for tissue hardness

Outcome Measures

Primary Outcome Measures

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

Assessment of the value of renal transplant imaging by elastography compared to standard ultrasound [by the time up to 100 images are obtained]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

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