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Functional, Dynamic, and Anatomic MR Urography

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585767
First Posted: January 3, 2008
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
  Purpose
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.

Condition
Hydronephrosis

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Functional, Dynamic, and Anatomic MR Urography

Further study details as provided by University of California, Davis:

Enrollment: 0
Study Start Date: April 2001
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with two kidneys
2
Patients with solitary kidney

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been diagnosed with obstructive uropathy
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585767


Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Richard Katzburg, MD University of California, Davis
  More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00585767     History of Changes
Other Study ID Numbers: 200311391
First Submitted: December 26, 2007
First Posted: January 3, 2008
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
Hydronephrosis

Additional relevant MeSH terms:
Hydronephrosis
Kidney Diseases
Urologic Diseases