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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This study has been withdrawn prior to enrollment.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

December 26, 2007
May 15, 2013
April 2001
May 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00585767 on ClinicalTrials.gov Archive Site
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Functional, Dynamic, and Anatomic MR Urography
Functional, Dynamic, and Anatomic MR Urography

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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients who have been diagnosed with obstructive uropathy
Hydronephrosis
Not Provided
  • 1
    Patients with two kidneys
  • 2
    Patients with solitary kidney
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2013
May 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00585767
200311391
No
David Shelton, MD, University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: Richard Katzburg, MD University of California, Davis
University of California, Davis
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP