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

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ClinicalTrials.gov Identifier: NCT04442724
Recruitment Status : Recruiting
First Posted : June 23, 2020
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Maurice M. Garcia, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Urinary Bladder Neoplasm Urologic Neoplasms Neoplasms Urinary Bladder Diseases Procedure: Fiducial marker placement Diagnostic Test: Multiparametric MRI (mpMRI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: Fiducial marker placement
placement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection

Diagnostic Test: 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 Measures :
  1. Bladder volume differential [ Time Frame: Baseline, after marker placement (anticipated to occur between study days 0-1) ]
    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 :
  1. Net dose radiation to collateral organs differential [ Time Frame: Baseline, after marker placement (anticipated to occur between study days 0-1) ]
    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

  2. Positive Predictive Value of mpPRI [ Time Frame: at the time of initial TURBT (Day 1), at the initial post-treatment surveillance cystoscopy (3 months post-treatment) ]
    percentage of actual positive sites among those predicted positive by mpMR

  3. Difference in alignment when markers are incorporated into the planning [ Time Frame: Radiotherapy treatment period (Days 14-28) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442724


Contacts
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Contact: Jenny Park, MPH 310-423-8762 jenny.park@cshs.org
Contact: Laura Sarmiento, CCRP 310-423-4295 laura.sarmiento@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center (CSMC) Recruiting
Los Angeles, California, United States, 90048
University of California San Francisco (UCSF) Not yet recruiting
San Francisco, California, United States, 94143
United States, Massachusetts
Harvard School of Medicine/Massachusetts General Hospital (MGH) Not yet recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Cedars-Sinai Medical Center
National Cancer Institute (NCI)
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Responsible Party: Maurice M. Garcia, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04442724    
Other Study ID Numbers: IIT2017-12-Garcia-FMBRT
1R01CA201709-01 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maurice M. Garcia, Cedars-Sinai Medical Center:
Fiducial marker
Fiducial marker guided technique
Additional relevant MeSH terms:
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Neoplasms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urinary Bladder Diseases
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases