RecruitingNot ApplicableNCT04442724

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

Sponsor

Cedars-Sinai Medical Center

Enrollment

60 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Neoplasms Urinary Bladder Neoplasm Urologic Neoplasms Urinary Bladder Diseases

Summary

The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether using small markers placed inside the bladder (called fiducial markers) combined with advanced MRI scans can help doctors deliver radiation therapy more precisely for bladder cancer. **You may be eligible if...** - You have been diagnosed with bladder cancer (urothelial/transitional cell carcinoma) - You are scheduled to receive radiation therapy as part of your treatment plan - Your cancer is confined to the bladder (no spread to distant organs) - You are 18 or older **You may NOT be eligible if...** - Your cancer originated in the ureter, urethra, or kidney, not the bladder - You have known spread of cancer to distant sites (lungs, liver, etc.) - You cannot safely undergo MRI (e.g., pacemaker) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFiducial marker placement

placement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection

DIAGNOSTIC_TESTMultiparametric MRI (mpMRI)

In this study, mp-MRI is defined as MRI that includes T1 \& T2 weighted sequences, diffusion weighted sequences, and Dynamic contrast enhanced (DCE) MRI sequences.

Locations(3)

Cedars-Sinai Medical Center (CSMC)

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Harvard School of Medicine/Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States

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NCT04442724

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