Ureteral ObstructionPhase 4NCT00301470
Functional MR Urography
A Phase 4 study testing MR urography in people with Ureteral Obstruction, run by Central Hospital, Nancy, France at 16 sites in France.
Trial summary
The objective of functional Uro MR is to add to an initial morphological phase, based on T2 and T1 weighted MR sequences, a sequential contrast-enhanced acquisition allowing to obtain functional semi-quantitative parameters from time-intensity curves from ROIs placed on the aorta, renal parenchyma and cavities. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Ureteral Obstruction
- What is being tested?
- MR urography
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- 16 sitesFrance
- Study dates
- Mar 2006to Mar 2008
- Phase
- Phase 4
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- children (age > 1 month) and adults chronic or intermittent urinary obstruction suspected by the demonstration of uni- or bilateral dilatation of pelvo-caliceal cavities by ultrasound or CT scan.
- undergoing both renal scintigraphy and MR within a month
Who cannot join
- acute urinary obstruction unilateral renal agenesia and ectopic kidney renal transplantation contra-indications to MR : pace-maker, claustrophobia contra-indications to the administration of Gadolinium chelates, including pregnancy, allergy
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Chu Angers
Angers, 49033
Chu Bordeaux
Bordeaux, 33076
Chru Lille
Lille, 59037
Ap-Hm Marseille
Marseille, 13005
Fondation LENVAL
Nice, 06200
AP-HP Trousseau
Paris, 75571
AP-HP Saint Vincent de Paul
Paris, 75674
AP-HP Robert Debré
Paris, 75935
AP-HP Bicêtre
Paris, 94275
Chu Poitiers
Poitiers, 86021
Chu Reims
Reims, 51092
Chu Rennes
Rennes, 35033
Chu Rouen
Rouen, 76031
Chu Strasbourg
Strasbourg, 67091
Chu Tours
Tours, 37044
CHU NANCY Hôpital Brabois enfant
Vandœuvre-lès-Nancy, 54011
About this study
Official title: Interest of MR Urography in the Evaluation of Functional Consequences of Urinary Tract in Children and Adults
The objective of functional Uro MR is to add to an initial morphological phase, based on T2 and T1 weighted MR sequences, a sequential contrast-enhanced acquisition allowing to obtain functional semi-quantitative parameters from time-intensity curves from ROIs placed on the aorta, renal parenchyma and cavities. If the equivalence with the renal scintigraphy is demonstrated, it would be possible to have both the morphological and functional approach of an obstructed kidney in one MR examination, without exposure to diagnostic irradiation.
Read the detailed description
The initial management and the follow-up of a patient presenting with chronic or intermittent obstruction is depending on clinical, biological factors and of imaging data, including the presence and degree of dilatation of pelvo-caliceal cavities and of functional consequences of such an obstruction.
The primary objectives of the study are:
- to evaluate the feasibility and reliability of the measurement of the relative renal function by MR urography compared to renal scintigraphy in the management of patients presenting with chronic and intermittent urinary obstruction in adults and children.
- if the accuracy of the two methods is demonstrated as equivalent, to conduct a medico-economic evaluation of functional MR Urography compared to renal scintigraphy, and show potential lower costs.
The secondary objectives are:
- to compare the diagnostic accuracy of various parameters of analysis of functional MR urography data, previously published in the literature, and determine indicators for predicting urinary obstruction
- to evaluate the interest of these indicators after surgical treatment of obstruction, or during the follow-up of patients
- to draw up a program of analysis and treatment of MR urography data, available for all centres whatever their MR unit.
The current study has a multicentric, observational, prospective design for the evaluation of a diagnostic strategy. It includes 16 French hospitals.
The main clinical hypothesis is that during one single MR examination, by the association of a morphological diagnostic phase and a functional phase, it will be possible to extract functional parameters having the same accuracy that renal scintigraphy in the determination of relative renal function.
The targeted recruitment is of 550 patients for two years. The MR and scintigraphy collected data will be reviewed in one site by experts at the end of the study. The university hospital of Nancy is in charge of coordinating the study.
Points of expected impact of the study are:
- a shortening of the duration of patients management by replacing two examinations (MR and scintigraphy) by one single examination (MR )
- a reduction of delivered exposure to diagnostic radiation, by eliminating renal scintigraphy in the initial diagnostic and follow-up of children an adults.
- potential applications in improving the spatial resolution of MR urography after correction of artefacts such as respiratory motion.
- the publication of clinical recommendations by the National Scientific Societies supporting the trial.
- Conditions
- Ureteral Obstruction
- Being tested
- MR urography
- Keywords
- Ureter, obstruction, Diagnostic techniques, urological, MRI, functional
- Medical subject headings
- Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR urographyDevice
undergoing both renal scintigraphy and MR within a month
What is being measured
The primary outcome is the main question the study is designed to answer.
Main medical criterion
percentage of relative renal function of the obstructed kidney
Main economical criterion
reduction of patient's management cost in the case of a suspicion of chronic or intermittent urinary obstruction
Secondary outcomes (2)
acceptability of the method by patient
reliability of the functional indicators provided by the software programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral ObstructionStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Investigators
- Michel CLAUDON, PhD, Principal investigator, Service de Radiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301470
- Sponsor's protocol ID
- PI 2005 - 01
- Status last verified
- Oct 2006
- First submitted
- 10 Mar 2006
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of MR Urography in the Evaluation of Functional Consequences of Urinary Tract in Children and Adults
- ClinicalTrials.gov ID
- NCT00301470
- Acronym / sponsor ID
- PI 2005 - 01
- Conditions
- Ureteral Obstruction
- Keywords
- Ureter, obstruction, Diagnostic techniques, urological, MRI, functional
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 13 Mar 2006 (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 objective of functional Uro MR is to add to an initial morphological phase, based on T2 and T1 weighted MR sequences, a sequential contrast-enhanced acquisition allowing to obtain functional semi-quantitative parameters from time-intensity curves from ROIs placed on the aorta, renal parenchyma and cavities. If the equivalence with the renal scintigraphy is demonstrated, it would be possible to have both the morphological and functional approach of an obstructed kidney in one MR examination, without exposure to diagnostic irradiation.
Detailed description
The initial management and the follow-up of a patient presenting with chronic or intermittent obstruction is depending on clinical, biological factors and of imaging data, including the presence and degree of dilatation of pelvo-caliceal cavities and of functional consequences of such an obstruction.
The primary objectives of the study are:
- to evaluate the feasibility and reliability of the measurement of the relative renal function by MR urography compared to renal scintigraphy in the management of patients presenting with chronic and intermittent urinary obstruction in adults and children.
- if the accuracy of the two methods is demonstrated as equivalent, to conduct a medico-economic evaluation of functional MR Urography compared to renal scintigraphy, and show potential lower costs.
The secondary objectives are:
- to compare the diagnostic accuracy of various parameters of analysis of functional MR urography data, previously published in the literature, and determine indicators for predicting urinary obstruction
- to evaluate the interest of these indicators after surgical treatment of obstruction, or during the follow-up of patients
- to draw up a program of analysis and treatment of MR urography data, available for all centres whatever their MR unit.
The current study has a multicentric, observational, prospective design for the evaluation of a diagnostic strategy. It includes 16 French hospitals.
The main clinical hypothesis is that during one single MR examination, by the association of a morphological diagnostic phase and a functional phase, it will be possible to extract functional parameters having the same accuracy that renal scintigraphy in the determination of relative renal function.
The targeted recruitment is of 550 patients for two years. The MR and scintigraphy collected data will be reviewed in one site by experts at the end of the study. The university hospital of Nancy is in charge of coordinating the study.
Points of expected impact of the study are:
- a shortening of the duration of patients management by replacing two examinations (MR and scintigraphy) by one single examination (MR )
- a reduction of delivered exposure to diagnostic radiation, by eliminating renal scintigraphy in the initial diagnostic and follow-up of children an adults.
- potential applications in improving the spatial resolution of MR urography after correction of artefacts such as respiratory motion.
- the publication of clinical recommendations by the National Scientific Societies supporting the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- children (age > 1 month) and adults chronic or intermittent urinary obstruction suspected by the demonstration of uni- or bilateral dilatation of pelvo-caliceal cavities by ultrasound or CT scan.
- undergoing both renal scintigraphy and MR within a month
Key exclusion criteria (1 listed)
- acute urinary obstruction unilateral renal agenesia and ectopic kidney renal transplantation contra-indications to MR : pace-maker, claustrophobia contra-indications to the administration of Gadolinium chelates, including pregnancy, allergy
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 |
|---|---|---|
| MR urographyundergoing both renal scintigraphy and MR within a month | Device | – |
Primary outcome
Main medical criterion
percentage of relative renal function of the obstructed kidney
Main economical criterion
reduction of patient's management cost in the case of a suspicion of chronic or intermittent urinary obstruction
2 secondary outcomes
acceptability of the method by patient
reliability of the functional indicators provided by the software programme
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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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.
Michel CLAUDON, PhD principal investigator
Service de Radiologie
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MR urography in people with Ureteral Obstruction, run by Central Hospital, Nancy, France at 16 sites in France.
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 2 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: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Main medical criterion. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2011.