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
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.
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.
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).
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 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
CTU to IVU Technical Performance Comparison: Opacification + Ability to Visualize Urothelial Segments
Chaan Ng, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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