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

NCT00567684 | Active Not Recruiting

• 2 other identifiers: 2007-0381NCI-2014-01374
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Transitional Cell Carcinoma; Urothelial Cancer; Bladder Cancer; Computed Tomography Urography; CTU; Intravenous Urography; IVU; TCC; transitional cell carcinomas

Outcome Measures

Primary Outcomes (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.

  2 Years

Study Arms (1)

CTU + IVU

EXPERIMENTAL

CTU = Computed Tomography Urography + IVU = Intravenous Urography

Device: Computed Tomography Urography (CTU); Other: Intravenous Urography (IVU)

Interventions

Computed Tomography Urography (CTU) DEVICE

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

Also known as: CTU

CTU + IVU

Intravenous Urography (IVU) OTHER

A routine IVU procedure performed prior to or after CTU.

Also known as: IVU

CTU + IVU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Upper tract TCC.
• \>18 years age.
• Written informed consent will be obtained from patients.

You may not qualify if:

• Elevated serum creatinine of \>2
• Allergy to intravenous CT contrast media
• Ureteral stint present or removed within six weeks
• Women of child bearing potential

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• GE Healthcare: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Chaan Ng, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: November 15, 2007
• Primary Completion (Estimated): November 30, 2034
• Study Completion (Estimated): November 30, 2034
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)