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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


  • Org Study ID: IIT2017-12-Garcia-FMBRT
  • Secondary ID: 1R01CA201709-01
  • NCT ID: NCT04442724
  • NCT Alias:
  • Sponsor: Cedars-Sinai Medical Center - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting July 1, 2020 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Bladder volume differential

Primary Outcome 1 - Time Frame: 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

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Jenny Park, MPH

Phone: 310-423-8762

Email: jenny.park@cshs.org

Locations

Facility Status Contact
Cedars-Sinai Medical Center (CSMC)
Los Angeles, California 90048
United States
Recruiting
University of California San Francisco (UCSF)
San Francisco, California 94143
United States
Not yet recruiting
Harvard School of Medicine/Massachusetts General Hospital (MGH)
Boston, Massachusetts 02114
United States
Not yet recruiting