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Bladder Fiducial Markers and Mp-MRI for Bladder Cancer

This study is looking at ways to improve radiation treatment for bladder cancer. Researchers are testing if placing small 24-karat gold markers (fiducial markers) around a bladder tumor helps doctors target radiation more accurately. They also want to see if a special type of MRI, called multiparametric MRI (mp-MRI), can find bladder cancer earlier and more precisely, especially when it's not visible with a scope. You might be able to join if you have muscle-invasive bladder cancer (T2-T4a, Nx, M0) and are planning to receive chemoradiation to preserve your bladder. The main goal is to see how bladder volume changes after the markers are placed. The study aims to enroll 60 participants, but its current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 60 participants. It is studying the use of fiducial markers and mp-MRI in patients with bladder cancer.
What's involved
You would have fiducial markers placed around your tumor site during surgery. You would also undergo multiparametric MRI scans.
Compensation
Not stated in the trial record.
Follow-up
Bladder volume will be measured at baseline and after marker placement, which is expected to occur between study days 0-1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04442724

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

Recruiting
NAAges 18+InterventionalTreatment
Cedars-Sinai Medical Center
~60 participants
Updated 2025-08-14 on ClinicalTrials.gov
What's tested:Fiducial marker placementMultiparametric MRI (mpMRI)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bladder volume differential
Measured over Baseline, after marker placement (anticipated to occur between study days 0-1)

Conditions

Bladder Cancer
Urinary Bladder Neoplasm
Urologic Neoplasms
Neoplasms
Urinary Bladder Diseases

Explore related trials

Bladder Carcinoma

NCT04442724

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Harvard School of Medicine/Massachusetts General Hospital (MGH)

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • University of California Los Angeles

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Cedars-Sinai Medical Center (CSMC)

    Los Angeles, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Maurice Garcia, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Laura Sarmiento, CCRP
[email protected]
310-423-4295
Email the study team

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Eligibility criteria

Inclusion

Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern.
Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder
Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation
Adequate renal function: Serum creatinine \< 2 mg/dL OR calculated creatinine clearance (CrCl) \> 30ml/min
Ability to understand and willingness to sign a written informed consent
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation
Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

Exclusion

Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed
Known distant metastatic disease (e.g. pulmonary or hepatic metastases)
Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed
Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection)
Planned (or prior history of) definitive bladder irradiation
Intravesical chemo- or biologic therapy within 6 weeks of first treatment
Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion
Clinically significant active infection or uncontrolled medical condition that would preclude participation in study
Pregnant or nursing women are excluded
Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment
Individuals with severe renal failure and cannot receive MRI contrast

What this trial measures

  • Bladder volume differentialBaseline, after marker placement (anticipated to occur between study days 0-1)

    Change in bladder volumes targeted for high dose radiation (HDR) between the first (Baseline) dose volume histogram (DVH) without the fiducial markers present, compared to the second DVH made after placement of the fiducial markers