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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

11600-Alanine aminotransferase increased

16800-Bladder infection

44800-Infections and infestations - Other specify

58700-Nystagmus

15000-Aspartate aminotransferase increased

88500-White blood cell decreased

15300-Ataxia

33900-Fever

25700-Diarrhea

43100-Hypokalemia

69700-Rash maculo-papular(targeted toxicity)

13200-Anemia

33300-Febrile neutropenia

57600-Nausea(targeted toxicity)

20500-Catheter related infection

58300-Neutrophil count decreased

41300-Hypercalcemia

41400-Hyperglycemia(targeted toxicity)

41600-Hyperkalemia

42600-Hypoalbuminemia

42700-Hypocalcemia

64400-Personality change

41500-Hyperhidrosis

13500-Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Chemotherapy, Immunoglobulin Therapy)

Arm II (Chemotherapy, Observation)

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

~1160

0 / 4Eligibility criteria met