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

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

INTRODUCTION

  • Org Study ID: IIT2017-12-Garcia-FMBRT
  • Secondary ID: 1R01CA201709-01
  • NTC ID: NCT04442724
  • Sponsor: 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.

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.

  • Overall Status
    Recruiting
  • Start Date
    July 1, 2020
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Bladder volume differential

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

CONDITION

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

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Maurice Garcia, MD

Role: Principal Investigator

Affiliation: Cedars-Sinai Medical Center

Overall Contact

Name: Maurice Garcia, MD

Phone: 310-423-8762, 310-423-4295

Email: jenny.park@cshs.org, laura.sarmiento@cshs.org

LOCATION

Facility Status Contact
Facility: Cedars-Sinai Medical Center (CSMC)
Los Angeles, California 90048
United States
Status: Recruiting Contact: N/A