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

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ClinicalTrials.gov Identifier: NCT00567684
Recruitment Status : Active, not recruiting
First Posted : December 5, 2007
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment
Bladder Cancer Other: Computed Tomography Urography (CTU) Other: Intravenous Urography (IVU)

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
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
Actual Study Start Date : November 2007
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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.

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

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 Posted: December 5, 2007    Key Record Dates
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