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

This study is ongoing, but not recruiting participants.
GE Healthcare
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: December 3, 2007
Last updated: October 3, 2016
Last verified: October 2016
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: Intervention Model: Single Group Assignment
Masking: None (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:

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 ]
    Comparison of relative technical performance of computed tomography urography (CTU) to intravenous urography (IVU) using digital tomosynthesis, in terms of visualization and diagnostic quality of segments of the upper urinary tract.

Estimated Enrollment: 135
Study Start Date: November 2007
Estimated Primary Completion Date: November 2018 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 transitional cell carcinomas (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
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 identifier: NCT00567684

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00567684     History of Changes
Other Study ID Numbers: 2007-0381
NCI-2014-01374 ( Registry Identifier: NCI CTRP )
Study First Received: December 3, 2007
Last Updated: October 3, 2016

Keywords provided by M.D. Anderson Cancer Center:
Transitional Cell Carcinoma
Urothelial Cancer
Bladder Cancer
Computed Tomography Urography
Intravenous Urography
transitional cell carcinomas

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases processed this record on September 21, 2017