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Study Summary
No. 2007-0381:.......Bladder......Chaan Ng......Diagnostic Radiology
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Study Summary Title
Study Summary
Number:		2007-0381
Study 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
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Physician New Patient Referral
Name:Chaan NgPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Diagnostic RadiologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6759
Contact us about clinical trials
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General Information
Disease Group:BladderSupported By:N/A
Phase of Study:N/AReturn
Visit:		There will be no return visits associated with this protocol.
Treatment
Agents:		Computed Tomography Urography (CTU)
Intravenous Urography (IVU)		Home Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		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.
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Study Objectives / Outcomes
    Primary Objectives:
      1. To compare the 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 Objectives:
      1. To provide pilot data on the diagnostic accuracy of CT urography, when compared to IVUusing digital tomosynthesis, in the detection of upper tract urothelial tumors.
      2. To assess the added benefit of including a second delayed post-contrast scan to the CT urogram examination.
      3. To document the extra-urothelial information obtained in CTU and IVU using digital tomosynthesis.
      4. To compare the relative radiation dose delivered in CTU and IVU using digital tomosynthesis.
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Study Status Information
Study Activation / Registration Date:11/15/2007
IRB Review and Approval Date:11/15/2007
Study Type:Other
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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 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.
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Links
Registration Number: NCT00567684
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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