- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00585767
Functional, Dynamic, and Anatomic MR Urography
May 25, 2017 updated by: University of California, Davis
This is a clinical feasibility study to assess the value of MR imaging for obtaining functional, dynamic and anatomical information in a comprehensive imaging protocol in subjects having obstructive uropathy.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
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
Sampling Method
Non-Probability Sample
Study Population
Patients who have been diagnosed with obstructive uropathy
Description
Inclusion Criteria:
- Males or females 18 years of age or older.
- All female patients of childbearing potential must agree to use a medically accepted method of contraception at the time of the study.
- Patients must have the ability to understand the requirements of the study, provide written and informed consent to participate, and agree to abide by the study requirements.
- Patients who have known or suspected hydronephrosis or patients with solitary kidneys.
Exclusion Criteria:
- Patients with known or suspected hypersensitivity to gadolinium-based agents.
- Patients who are pregnant or lactating.
- Patients with a condition that is a contraindication to MRI (e.g., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other conditions that would preclude patient proximity to a strong external magnetic field).
- Patients with a recent history of hemolytic anemia, sickle cell anemia or other hemoglobinopathy.
- Patients with a history of significant claustrophobia.
- Patients with impaired renal function based on 24-hr urine collection (creatinine clearance <10 ml/min or serum creatinine >1.8 mg/dl)
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
Cohorts and Interventions
Group / Cohort |
---|
1
Patients with two kidneys
|
2
Patients with solitary kidney
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Katzburg, MD, University of California, Davis
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
April 1, 2001
Primary Completion (Anticipated)
May 1, 2013
Study Completion (Anticipated)
May 1, 2013
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
January 2, 2008
First Posted (Estimate)
January 3, 2008
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 25, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200311391
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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