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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 5, 2014
Last verified: September 2014
  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:


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 ]
    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 2015 (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 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 ClinicalTrials.gov identifier: NCT00567684

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

Locations
United States, Texas
University of Texas 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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00567684     History of Changes
Other Study ID Numbers: 2007-0381, NCI-2014-01374
Study First Received: December 3, 2007
Last Updated: September 5, 2014
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
transitional cell carcinomas

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 September 14, 2014