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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up radiotherapy treatment period (days 14-28)

Awards & highlights

FMBRT Trial 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.Check my eligibility

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.See study design

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.

FMBRT Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

FMBRT Trial 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

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

Primary outcome measures

Bladder volume differential

Secondary outcome measures

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)

FMBRT 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,803 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,926,073 Total Patients Enrolled

Maurice Garcia, MDPrincipal InvestigatorCedars-Sinai Medical Center

Frequently Asked Questions

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

Is access to this trial available for prospective participants?

"Affirmative. The study's details listed on clinicaltrials.gov demonstrate that recruitment is currently in progress; the trial was first posted on July 1st 2020 and last revised on September 13th 2022. There are 4 medical sites looking to enroll a total of 60 patients for this research project."

Answered by AI

How many participants is the trial currently permitting?

"Affirmative. Via clinicaltrials.gov, we can see that this study is actively recruiting patients since it was first posted on July 1st 2020 and re-examined as recently as September 13th 2022. The research requires 60 participants to be enrolled from 4 designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy

Maurice M. Garcia 2020. "Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04442724.

All > Cancer > Bladder Cancer