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.
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)
- Type of treatment
- Injection or infusion, Medical device
- 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
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 group | Role | What they receive |
|---|---|---|
| CTU + IVU | Experimental | CTU = 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.
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.
- First posted5 Dec 2007 (estimated)
- Study start15 Nov 2007
- Primary completion30 Nov 2034 (estimated)
- Study completion30 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Chaan Ng, MD, Principal investigator, M.D. Anderson Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00567684
- Acronym / sponsor ID
- 2007-0381
- Conditions
- Bladder Cancer
- Keywords
- Transitional Cell Carcinoma, Urothelial Cancer, Bladder Cancer, Computed Tomography Urography, CTU, Intravenous Urography, IVU, TCC
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 133 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 15 Nov 2007 (actual)
- Primary completion
- 30 Nov 2034 (estimated)
- Study completion
- 30 Nov 2034 (estimated)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTU + IVU | Experimental | Device: Computed Tomography Urography (CTU), Other: Intravenous Urography (IVU)CTU = Computed Tomography Urography + IVU = Intravenous Urography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- >18 years age.
- Written informed consent will be obtained from patients.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography Urography (CTU)Also: CTUCTU performed at least a day before or after the IVU procedure. | Device | CTU + IVU |
| Intravenous Urography (IVU)Also: IVUA routine IVU procedure performed prior to or after CTU. | Other | CTU + IVU |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaan Ng, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
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.