CTU vs IVU Scans for Bladder Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Elevated creatinine, Contrast allergy, Ureteral stint, Women childbearing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of two types of scans, CTU (computed tomography urography) and IVU (intravenous urography), to assess bladder cancer status. The main aim is to determine if CTU can be effective on its own for future patients. Suitable candidates for this trial include those with a confirmed diagnosis of certain bladder cancers, such as bladder tumors or a history of bladder cancer surgery. Participants should already be undergoing these scans as part of their regular care. As an unphased trial, this study allows participants to contribute to research that could enhance future bladder cancer diagnostics.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these scanning techniques are safe for assessing bladder cancer?

Research shows that both CT scans of the urinary system (CTU) and X-rays with dye (IVU) are generally safe, but key differences exist between them.

CTU is often used to check for bladder cancer. While most people tolerate it well, it involves more radiation and uses a special dye that can cause serious side effects, particularly for those with kidney problems or allergies.

IVU, in contrast, uses less radiation and a different type of dye, which might be safer for some individuals. Considering these differences is important when choosing the best test. Always discuss any concerns with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using CTU and IVU scans for bladder cancer because these imaging techniques offer different ways to see the urinary system. Unlike traditional methods like cystoscopy, which can be invasive, CTU provides detailed 3D images using advanced CT technology, offering a non-invasive way to spot abnormalities. IVU, on the other hand, highlights the urinary tract with contrast dye, making it easier to detect blockages or changes. This trial aims to discover whether combining these methods can improve the accuracy of bladder cancer detection, potentially leading to better patient outcomes.

What evidence suggests that this trial's scans could be effective for bladder cancer?

Research has shown that CT scans of the urinary system, known as Computed Tomography Urography (CTU), are very accurate in diagnosing bladder cancer. They correctly identify the disease 96-97% of the time and offer high reliability, with a 97.7% chance of avoiding a false positive result. Many health guidelines worldwide recommend CTU as the best method for diagnosing cancers in the urinary tract. In contrast, Intravenous Urography (IVU) is less effective, accurately diagnosing upper urinary tract tumors in only about 66.6% of cases. This trial will compare CTU and IVU, as evidence suggests that CTU surpasses IVU in detecting bladder cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Chaan Ng, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed urothelial cancer, including those who've had bladder tumors of Stage T3 or higher, cystectomies for bladder cancer, or upper tract TCC. Participants must consent and be referred for CTU as part of routine care. It's not suitable for individuals with high serum creatinine levels (>2), contrast media allergies, women who could become pregnant, or those who have had a ureteral stint placed or removed within six weeks.

Inclusion Criteria

I had surgery to remove my bladder due to cancer.

I am scheduled for IVU with digital tomosynthesis and a CT scan as part of my routine care.

I have cancer in the upper part of my urinary system.

Exclusion Criteria

I am a woman who could become pregnant.

I am allergic to IV dye used in CT scans.

I have had a ureteral stent placed or removed in the last six weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Diagnostic Procedure

Participants undergo CTU and IVU procedures to assess the technical efficacy of CTU compared to IVU

1 day

1 visit (in-person)

Follow-up

Participants' images are reviewed a second time by additional radiologists to compare findings

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography Urography (CTU)
• Intravenous Urography (IVU)

Trial Overview The study compares the effectiveness of Computed Tomography Urography (CTU) versus Intravenous Urography (IVU) in evaluating urothelial cancers. The aim is to determine if CTU can be used alone to assess these cancers effectively in future patients.

How Is the Trial Designed?

Group I: CTU + IVU Experimental Treatment 2 Interventions

CTU = Computed Tomography Urography + IVU = Intravenous Urography

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8525470/

The accuracy of computed tomography in the diagnosis ... CT reported only two false positive and six false negative results and the overall accuracy was 96-97%. In comparison to the final pathological reports, CT/CTU ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2779752

Assessment of Diagnostic Yield of Cystoscopy and ... The pooled diagnostic yield among all patients was 2.00% (95% CI, 1.30%-3.09%) for bladder cancer, 0.02% (95% CI, 0.0%-0.15%) for UTUC, and 0.18 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2950393025000828?via%3Dihub

Bladder cancer prevalence and diagnostic test accuracy For CT urography for bladder cancer (Table 4, Table 5), the sensitivity was 58.6% (95% CI 40.7–76.6) and the specificity was 97.7% (95% CI 95.1–100). Table 3.

4. ajronline.org ajronline.org/doi/full/10.2214/AJR.09.4147?doi=10.2214/AJR.09.4147

Positive Predictive Value of CT Urography in the Evaluation of ... RESULTS. The positive predictive value of CT urography for upper tract urothelial cancer was 53% (40/76) overall, 83% (29/35) for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11767069/

New Trends and Future Perspectives in the Diagnosis of ... Computed Tomography Urography. CTU is the gold standard technique that is proposed by most of the guidelines worldwide for the diagnostic ...

6. mdpi.com mdpi.com/2379-139X/8/2/54

Computerized Decision Support for Bladder Cancer ... We have developed a computerized artificial intelligence (AI)-based decision support system for muscle-invasive bladder cancer treatment ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10204399/

Computed Tomography Urography: State of the Art and Beyond A proposed deep-learning model based on CT images demonstrated good accuracy in establishing the muscle-invasive status of bladder cancer preoperatively [113].