Spots Global Cancer Trial Database for Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata

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Trial Identification

Brief Title: Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata

Official Title: An Open Label, Single Center, Pilot Study to Evaluate the Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata Scheduled for Hysterectomy

Study ID: NCT02410018

Conditions

Leiomyomata

Interventions

OCL 503 (uterine artery embolization)

Study Description

Brief Summary: This is a prospective, pilot, open-label, uncontrolled, safety and effectiveness study of uterine artery embolization with OCL 503 in women with leiomyomata who are scheduled for hysterectomy.

Detailed Description: Patients will be allocated to Cohort 1 or Cohort 2. Following pelvic angiogram to delineate the uterine vasculature, embolization procedures of the left and right uterine arteries (as required) will be performed on each patient, using OCL 503 as the embolic agent. Patients in Cohort 1 will proceed to hysterectomy 1 week after embolization, and patients in Cohort 2 will undergo hysterectomy 1 month after embolization. Tumor response, as measured by changes in leiomyomata size and perfusion, will be determined by Magnetic Resonance Imaging or Magnetic Resonance Angiography. Histology of the resected uterus will be conducted to evaluate inflammatory response and viable tumour tissue.