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Computed Tomography Urography (CTU) vs Intravenous Urography (IVU) on Patients at Risk of Urothelial Tumors

This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00567684
First received: December 3, 2007
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

The goal of this clinical research study is to use computed tomography urography (CTU) scans and intravenous urography (IVU) scans to check the status of urothelial cancer, in order to try to learn the level of effectiveness of possibly using CTU by itself in future patients.


Condition Intervention
Bladder Cancer
 Other: Computed Tomography Urography (CTU)
Other: Intravenous Urography (IVU)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study Assessing the Technical Efficacy of Computed Tomography Urography (CTU) vs Intravenous Urography (IVU) With Particular Focus on Patients at Risk of Urothelial Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • CTU to IVU Technical Performance Comparison: Opacification + Ability to Visualize Urothelial Segments [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: November 2007
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CTU + IVU
CTU = Computed Tomography Urography + IVU = Intravenous Urography
 Other: Computed Tomography Urography (CTU)
CTU performed at least a day before or after the IVU procedure.
Other Name: CTU
Other: Intravenous Urography (IVU)
A routine IVU procedure performed prior to or after CTU.
Other Name: IVU

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who will undergo IVU using digital tomosynthesis and staging abdomino-pelvic CT as part of their routine care, will be invited to participate in this study.
  2. Patients who have been referred for CTU will also be invited to participate in the study.
  3. Patients who have histologically proven TCC; or
  4. Patients who have bladder tumors of Stage >/= T3; or
  5. Patients who have had cystectomies for bladder cancer; or
  6. Patients who have upper tract TCC.
  7. Patients who are > 18 years of age.
  8. Written informed consent will be obtained from patients.

Exclusion Criteria:

  1. Elevated serum creatinine of >2.
  2. Allergy to intravenous CT contrast media.
  3. Ureteral stint present or removed within six weeks
  4. Women of child bearing potential.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567684

Contacts
Contact: Chaan Ng, MD 713-792-6759

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Chaan Ng, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
GE Healthcare
Investigators
Principal Investigator: Chaan Ng, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00567684     History of Changes
Other Study ID Numbers: 2007-0381
Study First Received: December 3, 2007
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Transitional Cell Carcinoma
Urothelial Cancer
Bladder Cancer
Computed Tomography Urography
 CTU
Intravenous Urography
IVU
TCC

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013