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Enhanced MRI for Bladder Cancer Staging

Phase < 1

Recruiting

Led By Jodi K Maranchie, MD

Research Sponsored by Jodi Maranchie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance status of ECOG 0 or 1

A papillary tumor identified by cystoscopy that has been scheduled for TURBT OR histologically proven MIBC that is clinically localized and amenable to surgical resection with curative intent

Must not have

Untreated urinary tract infection

Women with active pregnancy, lactation or plans to conceive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to use MRI to look for bladder cancer. A contrast agent is used to help better visualize the tumor. The MRI images are then reviewed by two radiologists to determine the stage of the cancer.

Who is the study for?

This trial is for adults aged 18-90 with bladder cancer, either scheduled for tumor removal or with muscle-invasive disease suitable for surgery. Participants must be able to consent, have a performance status of ECOG 0 or 1 (fully active or restricted in physically strenuous activity), and normal kidney function. Pregnant women, those with severe allergies to contrast agents used in MRI, extreme claustrophobia, incompatible implants, metastatic disease, urinary infections or urethral strictures cannot join.

What is being tested?

The study tests a new MRI protocol using Gadobutrol and Ferumoxytol as contrast agents to determine the stage of bladder cancer before surgery. Patients will receive one pre-contrast image followed by an instillation of the contrast solution through a catheter and then a post-contrast image. Two radiologists blind to pathology results will assess tumor presence and invasion depth.

What are the potential side effects?

Potential side effects may include allergic reactions to Gadobutrol or Ferumoxytol such as rash, hives; kidney issues due to contrast agent; discomfort from catheter placement; anxiety during MRI procedure especially if claustrophobic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have a bladder tumor scheduled for removal or a muscle-invasive bladder cancer suitable for surgery.

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My kidney function is within the normal range.

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I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a urinary tract infection that hasn't been treated.

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I am not pregnant, breastfeeding, or planning to become pregnant.

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I have a condition that prevents the use of a urinary catheter.

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection

Secondary study objectives

Accuracy of Magnetic Resonance Imaging to detect residual/recurrent bladder tumor

Rate of Adverse Events

Side effects data

From 2022 Phase 3 trial • 53 Patients • NCT00033293

19%

87900-Vomiting(targeted toxicity)

15%

11400-Agitation

58700-Nystagmus

16800-Bladder infection

11600-Alanine aminotransferase increased

44800-Infections and infestations - Other specify

58300-Neutrophil count decreased

41400-Hyperglycemia(targeted toxicity)

69700-Rash maculo-papular(targeted toxicity)

33900-Fever

33300-Febrile neutropenia

20500-Catheter related infection

42600-Hypoalbuminemia

43100-Hypokalemia

88500-White blood cell decreased

41300-Hypercalcemia

42700-Hypocalcemia

15300-Ataxia

64400-Personality change

13200-Anemia

57600-Nausea(targeted toxicity)

13500-Anorexia

15000-Aspartate aminotransferase increased

25700-Diarrhea

41600-Hyperkalemia

41500-Hyperhidrosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Chemotherapy, Immunoglobulin Therapy)

Arm II (Chemotherapy, Observation)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Magnetic Resonance ImagingExperimental Treatment3 Interventions

Prior to planned surgical resection, subjects will undergo a single Magnetic Resonance Imaging study: a single breath-hold pre-contrast image followed by sterile placement of a temporary urethral catheter for instillation of a 50mL solution containing Gadobutrol (4 mM) plus ferumoxytol (5 mM) and a second, single breath hold post-contrast image.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

0 / 8Eligibility criteria met