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Enhanced MRI for Bladder Cancer Staging

Q: How many participants will this research endeavor accommodate?

Affirmative, according to the data hosted on clinicaltrials.gov this study is actively recruiting participants. It was initially posted in June 2021 and last amended in October 2022; 42 volunteers are required from a single location.

Q: Is the age-limit for this research endeavor capped at 80 years old?

Inclusion in this research requires subjects to be between 18 and 90 years old.

Q: Are there qualifications that must be met to take part in this experiment?

This medical trial seeks 42 individuals, aged 18 to 90 and diagnosed with <a href="https://www.withpower.com/clinical-trials/bladder-cancer">bladder cancer</a>, who meet the following criteria: a papillary tumor identified by cystoscopy scheduled for TURBT or histologically confirmed MIBC that is clinically localized and suitable for surgical removal; creatinine levels under 1.5 times institutional upper limit of normal (ULN) OR Cockcroft-Gault formula yielding creatinine clearance over 50 mL/min/1.73 m2 if creatinine level exceeds ULN; ECOG 0 or 1 performance status; aptitude to comprehend and willingness to sign an informed consent document.

Q: Are there any available slots for study participants in this clinical trial?

Indeed, clinicaltrials.gov states that this study is still accepting applicants. The original listing was published on June 1st 2021 and the post was last updated as of October 7th 2022. 42 participants are required at a single site for this trial to be completed successfully.

Q: In what ways are Magnetic Resonance Imaging scans routinely employed?

Magnetic Resonance Imaging is a frequently utilized procedure for treating supravalvular aortic stenosis. It can also aid in magnetic resonance angiography, renal artery stenosis, and other <a href="https://www.withpower.com/clinical-trials/mri">MRI</a> conditions.

Q: Are there any antecedent studies utilizing Magnetic Resonance Imaging?

Presently, 21 clinical trials exploring Magnetic Resonance Imaging exist. Of those studies, 4 are in Phase 3 of the treatment process. Although the majority are based out of Worcester, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a>, 79 sites across the globe are running research on this therapy modality.

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

Select...

I am fully active or can carry out light work.

Select...

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

Select...

My kidney function is within the normal range.

Select...

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

~1190

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jodi MaranchieLead Sponsor

1 Previous Clinical Trials

42 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,639 Total Patients Enrolled

Jodi K Maranchie, MDPrincipal InvestigatorAssociate Professor

Media Library

Magnetic Resonance Imaging Clinical Trial Eligibility Overview. Trial Name: NCT04369560 — Phase < 1

Bladder Cancer Research Study Groups: Magnetic Resonance Imaging

Bladder Cancer Clinical Trial 2023: Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT04369560 — Phase < 1

Magnetic Resonance Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04369560 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants will this research endeavor accommodate?

"Affirmative, according to the data hosted on clinicaltrials.gov this study is actively recruiting participants. It was initially posted in June 2021 and last amended in October 2022; 42 volunteers are required from a single location."

Answered by AI

Is the age-limit for this research endeavor capped at 80 years old?

"Inclusion in this research requires subjects to be between 18 and 90 years old."

Answered by AI

Are there qualifications that must be met to take part in this experiment?

"This medical trial seeks 42 individuals, aged 18 to 90 and diagnosed with bladder cancer, who meet the following criteria: a papillary tumor identified by cystoscopy scheduled for TURBT or histologically confirmed MIBC that is clinically localized and suitable for surgical removal; creatinine levels under 1.5 times institutional upper limit of normal (ULN) OR Cockcroft-Gault formula yielding creatinine clearance over 50 mL/min/1.73 m2 if creatinine level exceeds ULN; ECOG 0 or 1 performance status; aptitude to comprehend and willingness to sign an informed consent document."

Answered by AI

Are there any available slots for study participants in this clinical trial?

"Indeed, clinicaltrials.gov states that this study is still accepting applicants. The original listing was published on June 1st 2021 and the post was last updated as of October 7th 2022. 42 participants are required at a single site for this trial to be completed successfully."

Answered by AI

In what ways are Magnetic Resonance Imaging scans routinely employed?

"Magnetic Resonance Imaging is a frequently utilized procedure for treating supravalvular aortic stenosis. It can also aid in magnetic resonance angiography, renal artery stenosis, and other MRI conditions."

Answered by AI

Are there any antecedent studies utilizing Magnetic Resonance Imaging?

"Presently, 21 clinical trials exploring Magnetic Resonance Imaging exist. Of those studies, 4 are in Phase 3 of the treatment process. Although the majority are based out of Worcester, Massachusetts, 79 sites across the globe are running research on this therapy modality."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Histology of the Bladder Wall for Bladder Cancer Staging

Jodi Maranchie 2021. "Virtual Histology of the Bladder Wall for Bladder Cancer Staging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04369560.

All > Bladder Cancer