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This study has been withdrawn prior to enrollment.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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014