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Functional, Dynamic, and Anatomic MR Urography

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
David Shelton, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00585767
First received: December 26, 2007
Last updated: May 15, 2013
Last verified: December 2007
History of Changes
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585767

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

No publications provided

Responsible Party: David Shelton, MD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00585767     History of Changes
Other Study ID Numbers: 200311391
Study First Received: December 26, 2007
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Hydronephrosis

Additional relevant MeSH terms:
Hydronephrosis
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013