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
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)
- PregnancyOutrightexclusionShow in the text
- Prior malignancyConditionalexclusionShow in the text
- RenalConditionalinclusion
creatinine < 2 mg/dL or CrCl > 30 ml/min
Show in the text
Recruiting in Massachusetts
- Harvard School of Medicine/Massachusetts General Hospital (MGH) · Boston, Suffolk County