Clinical Trial: Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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 MRI/MRA. Histology of the resected uterus will be conducted to evaluate inflammatory response and viable tumour tissue.
Sponsor: IMBiotechnologies Ltd.

Current Primary Outcome:

  • Short-term safety of OCL 503 at 7 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting [ Time Frame: 7 days ]
  • Change in fibroid perfusion from baseline at 7 days post treatment of women with leiomyomata by UAE [ Time Frame: 7 days ]
  • Short-term safety of OCL 503 at 28 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting [ Time Frame: 28 days ]
  • Change in fibroid perfusion from baseline at 28 days post treatment of women with leiomyomata by UAE [ Time Frame: 28 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tissue necrosis assessed by histology graded scale at 7 days post treatment of women with leiomyomata by UAE [ Time Frame: 7 days ]
  • Inflammatory response assessed by histology at 7 days post treatment of women with leiomyomata by UAE [ Time Frame: 7 days ]
  • Tissue necrosis assessed by histology graded scale at 28 days post treatment of women with leiomyomata by UAE [ Time Frame: 28 days ]
  • Inflammatory response assessed by histology at 28 days post treatment of women with leiomyomata by UAE [ Time Frame: 28 days ]


Original Secondary Outcome: Same as current

Information By: IMBiotechnologies Ltd.

Dates:
Date Received: March 6, 2015
Date Started: April 2015
Date Completion:
Last Updated: June 14, 2016
Last Verified: June 2016