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

Primary Purpose

Bladder Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography Urography (CTU)
Intravenous Urography (IVU)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Transitional Cell Carcinoma, Urothelial Cancer, Bladder Cancer, Computed Tomography Urography, CTU, Intravenous Urography, IVU, TCC, transitional cell carcinomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CTU + IVU

Arm Description

CTU = Computed Tomography Urography + IVU = Intravenous Urography

Outcomes

Primary Outcome Measures

CTU to IVU Technical Performance Comparison: Opacification + Ability to Visualize Urothelial Segments
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.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2007
Last Updated
October 5, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00567684
Brief Title
Computed Tomography Urography (CTU) vs Intravenous Urography (IVU) on Patients at Risk of Urothelial Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2007 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
GE Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background for the Study: Currently, IVU is used to detect urothelial tumors and then computed tomography (CT) scans are performed after that, to check the status of the disease. This is typically done every 3 months for the first 2 years after diagnosis, and then every 6 months for the next 2 years. Researchers want to learn if this current routine method of using 2 diagnostic procedures can be replaced with CTU alone, in future patients. CTU uses the same scanner machine as CT scans do. The difference between these 2 types of scans is that in addition to collecting the same type of images and information that CT scans do, CTU may also allow the doctor to look at the lining of the tubes that carry urine from the bladder. Looking at the lining of these tubes is something that IVU is used for, and researchers want to find out if CTU can also be used for this purpose. Study Procedures: If you are found to be eligible to take part in this study, you will have a CTU procedure performed at least a day before or after your routine IVU. If your doctor has ordered a CT of your abdomen and pelvis and IVU, the CTU will be performed instead of a routine CT scan of the abdomen and pelvis that would normally occur. If your doctor has ordered just a CTU, you will have an IVU as well. CTU Procedure: The CTU procedure is very similar to the standard CT of the abdomen/pelvis that you would otherwise receive along with an ITU. To prepare for the CTU, you will be asked to drink contrast solution (a type of dye) in order to allow the tumor(s) to be more easily seen and checked. You will be given about 30 ounces (3 3/4 cups) of contrast solution to drink at 30 minutes before the CTU and another 7 ½ ounces (about a cup) of contrast solution to drink while you are on the scanning table. You will also receive Lasix (furosemide) by injection. Furosemide is given to help the tubes in your kidney dilate (expand) to improve the quality of the images. For the CTU , you will lie flat on a CT scanner and will receive additional contrast solution by vein during the scan. While the scan is being performed, you will be asked to hold your breath several times, for about 15-20 seconds each time. The process of having the CTU performed should take about 10 minutes longer than a regular CT scan. If the images are not clear enough, all or part of the scanning process may need to be repeated (without repeating the contrast). IVU Procedure: Either before the CTU or after it, depending on the order in which you were assigned to receive these procedures, you will receive the IVU as part of your routine care. Length of Study Participation: After one set of IVU and CTU scans have been performed, your participation in this study will be over. At least 3 months after your scans are performed, your images will be reviewed a second time by 2 additional M. D. Anderson doctors (radiologists) to compare their findings with the original radiologist's findings. This is an investigational study. The routine way to check the status of urothelial cancer is to use IVU and CT scanning. It is considered experimental, however, to use CTU instead of routine CT scanning for checking the status of urothelial cancer. At this time, using CTU for this purpose is being done in research only. Up to 135 patients will take part in this study. All will be enrolled at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Transitional Cell Carcinoma, Urothelial Cancer, Bladder Cancer, Computed Tomography Urography, CTU, Intravenous Urography, IVU, TCC, transitional cell carcinomas

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTU + IVU
Arm Type
Experimental
Arm Description
CTU = Computed Tomography Urography + IVU = Intravenous Urography
Intervention Type
Device
Intervention Name(s)
Computed Tomography Urography (CTU)
Other Intervention Name(s)
CTU
Intervention Description
CTU performed at least a day before or after the IVU procedure.
Intervention Type
Other
Intervention Name(s)
Intravenous Urography (IVU)
Other Intervention Name(s)
IVU
Intervention Description
A routine IVU procedure performed prior to or after CTU.
Primary Outcome Measure Information:
Title
CTU to IVU Technical Performance Comparison: Opacification + Ability to Visualize Urothelial Segments
Description
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.
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patients who have been referred for CTU will also be invited to participate in the study. Patients who have histologically proven transitional cell carcinomas (TCC); or Patients who have bladder tumors of Stage >/= T3; or Patients who have had cystectomies for bladder cancer; or Patients who have upper tract TCC. Patients who are > 18 years of age. Written informed consent will be obtained from patients. Exclusion Criteria: Elevated serum creatinine of >2. Allergy to intravenous CT contrast media. Ureteral stint present or removed within six weeks Women of child bearing potential.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaan Ng, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

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