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

a study on Bladder Cancer Urinary Bladder Tumor Urologic Neoplasms Neoplasms Urinary Bladder Diseases

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Details

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.

Keywords

Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases, Fiducial marker, Fiducial marker guided technique, Urinary Bladder Neoplasms, Fiducial marker placement, Multiparametric MRI (mpMRI)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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
  • 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

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Cedars-Sinai Medical Center (CSMC) accepting new patients
    Los Angeles California 90048 United States
  • Harvard School of Medicine/Massachusetts General Hospital (MGH) accepting new patients
    Boston Massachusetts 02114 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cedars-Sinai Medical Center
ID
NCT04442724
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated