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

NCT04442724 | Recruiting FDA Device

• 2 other identifiers: IIT2017-12-Garcia-FMBRT1R01CA201709-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Keywords

Fiducial marker; Fiducial marker guided technique

Outcome Measures

Primary Outcomes (1)

• Bladder volume differential

  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

  Baseline, after marker placement (anticipated to occur between study days 0-1)

Secondary Outcomes (3)

• Net dose radiation to collateral organs differential

  Baseline, after marker placement (anticipated to occur between study days 0-1)

• Positive Predictive Value of Multiparametric-MRI (mp-MRI)

  at the time of initial TURBT (Day 1), at the initial post-treatment surveillance cystoscopy (3 months post-treatment)

• Difference in alignment when markers are incorporated into the planning

  Radiotherapy treatment period (Days 14-28)

Study Arms (1)

Single Arm - Bladder Chemo-Radiotherapy

EXPERIMENTAL

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.

Procedure: Fiducial marker placement; Diagnostic Test: Multiparametric MRI (mpMRI)

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

Single Arm - Bladder Chemo-Radiotherapy

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.

Single Arm - Bladder Chemo-Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Cedars-Sinai Medical Center (CSMC)

Los Angeles, California, 90048, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Harvard School of Medicine/Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urologic Neoplasms; Neoplasms; Urinary Bladder Diseases

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Maurice Garcia, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Sarmiento, CCRP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 23, 2020
• Study Start: July 1, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)