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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT04442724
Status
Recruiting
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Conditions

  • Bladder Cancer
  • Neoplasms
  • Urinary Bladder Diseases
  • Urinary Bladder Neoplasm
  • Urologic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fiducial marker placement — PROCEDURE
    placement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection
  • Multiparametric MRI (mpMRI) — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2020
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center (CSMC)Los AngelesCalifornia90048-
University of California Los AngelesLos AngelesCalifornia90095
Jackie Hernandez, CCRP
[email protected]
310-267-8991
Harvard School of Medicine/Massachusetts General Hospital (MGH)BostonMassachusetts02114

Find similar trials in Los Angeles, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Cedars-Sinai Medical Center (CSMC)· Los Angeles, CAUniversity of California Los Angeles· Los Angeles, CAHarvard School of Medicine/Massachusetts General Hospital (MGH)· Boston, MA

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