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Bladder CancerNCT00567684

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

A study testing Computed Tomography Urography (CTU) and Intravenous Urography (IVU) in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Computed Tomography Urography (CTU) and Intravenous Urography (IVU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
1 siteUnited States
Study dates
15 Nov 2007to 30 Nov 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Such patients will typically
  • Have histologically proven TCC, or
  • Have bladder tumors of Stage ≥ T3, or
  • Had cystectomies for bladder cancer, or
Show all 14Show fewer
  • Upper tract TCC.
  • >18 years age.
  • Written informed consent will be obtained from patients.
  • Patient 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Bladder Cancer
Being tested
Computed Tomography Urography (CTU), Intravenous Urography (IVU)
Keywords
Transitional Cell Carcinoma, Urothelial Cancer, Bladder Cancer, Computed Tomography Urography, CTU, Intravenous Urography, IVU, TCC, transitional cell carcinomas
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed Tomography Urography (CTU)Device

    Also called CTU

    CTU performed at least a day before or after the IVU procedure.

  • Intravenous Urography (IVU)Other

    Also called IVU

    A routine IVU procedure performed prior to or after CTU.

Study groups in NCT00567684
Study groupRoleWhat they receive
CTU + IVUExperimentalCTU = Computed Tomography Urography + IVU = Intravenous Urography
Receives: Device: Computed Tomography Urography (CTU); Other: Intravenous Urography (IVU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2007 (estimated)
  2. Study start15 Nov 2007
  3. Primary completion30 Nov 2034 (estimated)
  4. Study completion30 Nov 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00567684
Sponsor's protocol ID
2007-0381
Other IDs
NCI-2014-01374
Status last verified
Oct 2026
First submitted
3 Dec 2007
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Computed Tomography Urography (CTU) and Intravenous Urography (IVU) in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CTU to IVU Technical Performance Comparison: Opacification + Ability to Visualize Urothelial Segments (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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