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Trial NCT04442724

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

Phase
Not given
Sponsor
Cedars-Sinai Medical Center
Conditions
Bladder Cancer; Urinary Bladder Neoplasm; Urologic Neoplasms; Neoplasms; Urinary Bladder Diseases
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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/minRenal * 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 excludedPregnancy * Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatmentPrior malignancy * Individuals with severe renal failure and cannot receive MRI contrast

Restrictions found (3)

Recruiting in Massachusetts

  • Harvard School of Medicine/Massachusetts General Hospital (MGH) · Boston, Suffolk County