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

NCT ID: NCT04442724

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2026-06-30

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.

Detailed Description

This study of fiducial markers in patients with localized muscle-invasive bladder cancer will enroll patients electing bladder preservation with tri-modal therapy.

24-K gold fiducial markers will be endoscopically implanted around the tumor resection area to mark the location of the tumor site, into the bladder wall submucosa space under direct visualization via a coaxial needle. The markers are visible on all imaging modalities, including all available on-table imaging (e.g., portal and cone-beam CT) used for radiotherapy. Reliable fiducial marker placement within the bladder may have the potential to advance bladder-sparing management of localized muscle-invasive bladder cancer.

This study will examine the effectiveness of bladder-preserving multi-modal treatment of muscle-invasive bladder cancer with and without fiducial marker placement to guide radiotherapy targeting and to minimize collateral radiation. In addition, this study intends to verify the accuracy and report on the sensitivity and specificity of mp-MRI imaging to detect the presence and location of bladder cancer.

Conditions

Bladder Cancer; Urinary Bladder Neoplasm; Urologic Neoplasms; Neoplasms; Urinary Bladder Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fiducial marker placement

Intervention Type: PROCEDURE

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

Multiparametric MRI (mpMRI)

Intervention Type: 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.

Interventions

Fiducial marker placement

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

Intervention Type: PROCEDURE

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Maurice M. Garcia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maurice Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center (CSMC)

Los Angeles, California, United States

Site Status: RECRUITING

University of California Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Harvard School of Medicine/Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laura Sarmiento, CCRP

Role: CONTACT

laura.sarmiento@cshs.org

310-423-4295

Facility Contacts

Jackie Hernandez, CCRP

Role: primary

jhernandez@mednet.ucla.edu

310-267-8991

Sarah Stec

Role: primary

SSTEC@mgh.harvard.edu

Other Identifiers

1R01CA201709-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IIT2017-12-Garcia-FMBRT

Identifier Type: -

Identifier Source: org_study_id