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

Primary Purpose

Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasms

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fiducial marker placement

Multiparametric MRI (mpMRI)

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Fiducial marker, Fiducial marker guided technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cedars-Sinai Medical Center (CSMC)Recruiting
University of California Los AngelesRecruiting
Harvard School of Medicine/Massachusetts General Hospital (MGH)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm - Bladder Chemo-Radiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Net dose radiation to collateral organs differential

comparison of a DVH (Dose Volume Histogram) made without the fiducial markers present, to the second DVH made with the fiducial markers present. This will be measured by net dose (Gy to area and/or volume) to collateral organs

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

percentage of actual positive sites among those predicted positive by mpMRI

Difference in alignment when markers are incorporated into the planning

Difference in "on-table" patient alignment under the radiotherapy gantry (in millimeters, in X, Y and Z dimensions) when the patient is aligned daily based on conventional methods only (i.e. fiducial markers are not used for alignment), and when the patient is aligned based on the fiducial markers as the reference.

Full Information

NCT ID

NCT04442724

First Posted

June 18, 2020

Last Updated

September 23, 2023

Sponsor

Cedars-Sinai Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04442724

Brief Title

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

Acronym

FMBRT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases

Keywords

Fiducial marker, Fiducial marker guided technique

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single Arm - Bladder Chemo-Radiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Fiducial marker placement

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Multiparametric MRI (mpMRI)

Intervention Description

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 Information:

Title

Bladder volume differential

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Net dose radiation to collateral organs differential

Description

Time Frame

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

Title

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

Description

percentage of actual positive sites among those predicted positive by mpMRI

Time Frame

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

Title

Difference in alignment when markers are incorporated into the planning

Description

Time Frame

Radiotherapy treatment period (Days 14-28)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Sarmiento, CCRP

Phone

310-423-4295

laura.sarmiento@cshs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maurice Garcia, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center (CSMC)

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Name

University of California Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jackie Hernandez, CCRP

Phone

310-267-8991

jhernandez@mednet.ucla.edu

Facility Name

Harvard School of Medicine/Massachusetts General Hospital (MGH)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Stec

SSTEC@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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