Recruiting

Bladder Fiducial Markers & mp-MRI

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT04442724

Conditions

Bladder Cancer

Urinary Bladder Neoplasm

Urologic Neoplasms

Neoplasms

Urinary Bladder Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fiducial marker placement

Multiparametric MRI (mpMRI)

Study Details

Brief 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.

Conditions

Bladder Cancer

Urinary Bladder Neoplasm

Urologic Neoplasms

Neoplasms

Urinary Bladder Diseases

Study ID

NCT04442724

Start date

Jul 1, 2020

Status verified date

Aug, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arm - Bladder Chemo-Radiotherapy

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.

Interventions

Fiducial marker placement

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

Multiparametric 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.

Primary outcome measure

  • Bladder volume differential [ Time Frame: Baseline, after marker placement (anticipated to occur between study days 0-1) ]

Central Contacts and Locations

Central contacts

Laura Sarmiento, CCRP

310-423-4295laura.sarmiento@cshs.org

Locations

Cedars-Sinai Medical Center (CSMC)

Recruiting

Los Angeles, California, United States, 90048

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Jackie Hernandez, CCRP

310-267-8991jhernandez@mednet.ucla.edu

Harvard School of Medicine/Massachusetts General Hospital (MGH)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sarah Stec

SSTEC@mgh.harvard.edu

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Keywords

  • Fiducial marker
  • Fiducial marker guided technique

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2025-08-14.