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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567684
First Posted: December 5, 2007
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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: 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
Actual Study Start Date: November 2007
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2019 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567684


Locations
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
Investigators
Principal Investigator: Chaan Ng, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00567684     History of Changes
Other Study ID Numbers: 2007-0381
NCI-2014-01374 ( Registry Identifier: NCI CTRP )
First Submitted: December 3, 2007
First Posted: December 5, 2007
Last Update Posted: October 5, 2017
Last Verified: October 2017

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

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