Elastographic Imaging of Renal Transplants (Elastorenal)

July 7, 2009 updated by: The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: after up to 50 "normal" images are collected
after up to 50 "normal" images are collected

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the value of renal transplant imaging by elastography compared to standard ultrasound
Time Frame: by the time up to 100 images are obtained
by the time up to 100 images are obtained

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

July 9, 2009

Last Update Submitted That Met QC Criteria

July 7, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC-MS-06-0255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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