Testing Ruvidar® (TLD-1433) bladder for non-muscle invasive bladder cancer ("nmibc")

Exclusion

• −Past or current muscle invasive (i.e.: T2, T3, T4) or metastatic urothelial carcinoma.
• −Has concurrent extravesical (i.e.: urethra, ureter, renal pelvis, prostate or prostatic ducts) non-muscle invasive transitional cell carcinoma of the urothelium. (confirmed by staging to exclude extravesical disease, which may include radiological imaging and/or biopsy) within 3 months of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →:
• −If previous work up occurred more than 3 months prior to enrollment, staging for extravesical disease must be repeated prior to enrolment in order to determine eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →.
• −Active gross hematuria.
• −Currently receiving treatment with a prohibited concomitant therapy (refer to 12.2.1, Prohibited Medications).
• −Participated in a study with an investigational agent or device within 1 month from the first dose of current Study Procedure.
• −Have an active infection requiring systemic therapy, including active or intractable Urinary Tract Infection ("UTI"), not resolved prior to the procedure.
• −Has any contraindication to general or spinal anesthesia.
• −Is pregnant or breastfeeding within the projected duration of Study II, starting with the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more → through to two weeks following the last Study Procedure.
• −Have a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer or localized prostate cancer under active surveillance with Gleason 6 disease. A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable, provided that the following criteria are met: Stage T2N0M0 or lower Prostate-Specific Antigen ("PSA") undetectable for 2 years while off androgen deprivation therapy or no more than 2 consecutive rising PSAs.
• −Have a history or current evidence of any condition, therapy, surgery or laboratory abnormality that, in the opinion of the PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, might confound the results of the study, interfere with the patient's participation in the study, or is not in the best interest of the patient to participate.
• −Prior treatment with an intravesical chemotherapeutic agent within 1 month of the first dose of current Study Drug, with the exception of a single perioperative dose of chemotherapy immediately post-TURBT (not considered treatment).