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Trial Summary

Protocol No.TC-UT-03-P
StatusOPEN TO ACCRUAL
Principal InvestigatorKaimakliotis, Hristos
ScopeNational
PhasePhase III
Age GroupAdult
TitleA Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel on Ablation of Upper Urinary Tract Urothelial
DescriptionThe study is investigating the ability of UroGen's MitoGel? procedure to treat urothelial carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective this will lead to the development of a new treatment approach for patients suffering from Low Grade Upper Urinary Urothelial Carcinoma (UTUC).
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.
  • Patient has at least one (1) measurable and biopsy-confirmed papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15mm.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesUrethral Cancer
Participating InstitutionsIndiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
Treatment TypeTreatment
ContactPhone: (317) 278-5632
Email: iutrials@iu.edu