Functional, Dynamic, and Anatomic MR Urography - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00585767

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

MedlinePlus related topics: Anatomy

U.S. FDA Resources

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

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	90
Study Start Date:	April 2001
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (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

Locations

United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817

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 ( Richard Katzberg, M.D. )
Study ID Numbers:	200311391
Study First Received:	December 26, 2007
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00585767
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Hydronephrosis

Study placed in the following topic categories:

Hydronephrosis
Urologic Diseases
Kidney Diseases

ClinicalTrials.gov processed this record on January 16, 2009