Renal TransplantPhase 1ElastorenalNCT00935727
Elastographic Imaging of Renal Transplants
A Phase 1 study testing Elastographic imaging in people with Renal Transplant, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Elastographic imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (over 18) male or female renal transplant patient
- normally functioning
- or being evaluated for a possible problem
Who cannot join
- unwilling or unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Renal Transplant
- Being tested
- Elastographic imaging
- Keywords
- renal transplant, ultrasound, elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastographic imagingOther
ultrasound imaging using a specialized computer that processes the data for tissue hardness
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | normally functioning transplanted kidneys Receives: Other: Elastographic imaging |
| 2 | Other | transplanted kidney undergoing known rejection or other known abnormality Receives: Other: Elastographic imaging |
| 3 | Other | transplanted kidney with unknown diagnosis Receives: Other: Elastographic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: by the time up to 100 images are obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJun 2006
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: images obtained were non-diagnostic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Investigators
- Alan M Cohen, MD, Principal investigator, The University of Texas Health Science Center, HoustonJonathan Ophir, PhD, Study director, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935727
- Sponsor's protocol ID
- HSC-MS-06-0255
- Acronym
- Elastorenal
- Status last verified
- Jul 2009
- First submitted
- 8 May 2009
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15627731
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Define Parameters of Elastography Compared to Color Flow Doppler Ultrasound in Renal Transplants
- ClinicalTrials.gov ID
- NCT00935727
- Acronym / sponsor ID
- Elastorenal / HSC-MS-06-0255
- Conditions
- Renal Transplant
- Keywords
- renal transplant, ultrasound, elastography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: images obtained were non-diagnostic
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Study start
- Jun 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Elastographic imagingnormally functioning transplanted kidneys |
| 2 | Other | Other: Elastographic imagingtransplanted kidney undergoing known rejection or other known abnormality |
| 3 | Other | Other: Elastographic imagingtransplanted kidney with unknown diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (over 18) male or female renal transplant patient
- normally functioning
- or being evaluated for a possible problem
Key exclusion criteria (1 listed)
- unwilling or unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastographic imagingultrasound imaging using a specialized computer that processes the data for tissue hardness | Other | 1, 2, 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: images obtained were non-diagnostic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2009.
- Background: PubMed 15627731Weitzel 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.
- general information about elastographyLink provided by the sponsor.
Related trials for Renal Transplant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan M Cohen, MD principal investigator
The University of Texas Health Science Center, Houston
Jonathan Ophir, PhD study director
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elastographic imaging in people with Renal Transplant, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: images obtained were non-diagnostic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00935727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2009.