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Fiducial Markers + Mp-MRI for Bladder Cancer (FMBRT Trial)

N/A

Recruiting

Led By Maurice Garcia, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

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

Must have

Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder

Adequate renal function: Serum creatinine < 2 mg/dL OR calculated creatinine clearance (CrCl) > 30ml/min

Must not have

Known distant metastatic disease (e.g. pulmonary or hepatic metastases)

Clinically significant active infection or uncontrolled medical condition that would preclude participation in study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up radiotherapy treatment period (days 14-28)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether gold markers can help doctors better target radiation therapy for bladder cancer, and whether a new MRI technology can improve cancer detection.

Who is the study for?

This trial is for adults with bladder cancer (urothelial carcinoma) that's not spread beyond the pelvis. They should be set to receive chemo and radiation but haven't had major bladder surgery or recent intravesical therapy. Good kidney function is needed, and they must use birth control if applicable.

What is being tested?

The study tests placing tiny gold markers near the tumor before radiation so doctors can target it better. It also checks if a new type of MRI scan can more accurately detect bladder cancer when scopes don't see it.

What are the potential side effects?

Potential side effects may include discomfort from marker placement, typical MRI-related issues like claustrophobia or allergic reactions to contrast dye used during the scan.

Eligibility Criteria

Inclusion Criteria

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

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My bladder cancer is at a stage where it's not spread far and I'm choosing to get chemoradiation.

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My kidney function is good, with creatinine below 2 mg/dL or clearance above 30ml/min.

Exclusion Criteria

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

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My cancer has spread to distant parts of my body like the lungs or liver.

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I do not have any infections or uncontrolled conditions that would stop me from joining the study.

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I do not have bladder conditions that prevent safe medical marker placement.

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I am scheduled for or have had bladder radiation therapy.

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I have severe kidney problems and cannot have MRI dye.

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I am eligible for surgery to remove cancerous lymph nodes in my abdomen or pelvis.

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I do not have primary cancer in my ureter, urethra, or renal pelvis without bladder cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ radiotherapy treatment period (days 14-28)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~radiotherapy treatment period (days 14-28)

This trial's timeline: 3 weeks for screening, Varies for treatment, and radiotherapy treatment period (days 14-28) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Bladder volume differential

Secondary study objectives

Difference in alignment when markers are incorporated into the planning

Net dose radiation to collateral organs differential

Positive Predictive Value of Multiparametric-MRI (mp-MRI)

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: Single Arm - Bladder Chemo-RadiotherapyExperimental Treatment2 Interventions

Fiducial marker placement \& cystogram during resection surgery, followed by radiation planning CT scan, mpMRI, chemo-radiation treatment; mpMRI and/or surveillance cystoscopy at 3, 6, and 9 months post-treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fiducial marker placement

2003

Completed Phase 1

~20

0 / 9Eligibility criteria met