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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Leiomyomata
- Sponsor
- IMBiotechnologies Ltd.
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •presence of one or more of the following symptoms: abnormal menstrual bleeding, prolonged menstrual period, pelvic pain, or bulk-related symptoms that are attributed to uterine fibroids (bulk-related symptoms include pelvic pressure, abdominal distension, abdominal bloating, constipation, backache, urinary frequency, urinary retention, ureteral dilation, and rectal pressure), and the intensity of uterine fibroid-related symptoms, which are sufficiently sever to warrant hysterectomy, and the patient's medical history, physical examination, and the results of imaging by ultrasound or MRI;
- •are between the ages of 30 and 55 years, inclusive;
- •have had a pelvic examination by a gynaecologist within the previous 6 months;
- •have had a normal Pap smear within the last 12 months;
- •have had an endometrial biopsy within the previous three to six months, as appropriate to patient history;
- •are premenopausal with menstrual cycles lasting between 22 and 35 days. A follicle stimulating hormone (FSH) value obtained within three months prior to the procedure must be \< 40 IU/L;
- •are scheduled for total abdominal hysterectomy;
- •are willing and able to provide written, informed consent.
Exclusion Criteria
- •have been treated with gonadotropin-releasing hormone (GnRH) agonists within the previous 12 weeks;
- •have a American Society of Anesthesiologists (ASA) score ≥ 3;
- •have abnormally large ovarian arteries, as assessed by MRA and determined by the Investigator;
- •have an undiagnosed pelvic mass outside the uterus;
- •have claustrophobia or other contraindications to the performance of the pre- and post-procedure MRI studies including the presence of metal implants, metal plates, bone pins, bone screws, neurostimulators, cardiac pacemakers, aneurysm clips, cochlear or retinal implants, permanent hearing aids, or permanent eye-liner;
- •have pedunculated subserosal fibroids with an attachment to the uterus less than one third of the greatest diameter of the fibroid;
- •who do not agree to use contraceptives from Visit 1 until undergoing total abdominal hysterectomy;
- •have compromised hematopoietic function;
- •have hepatic dysfunction defined as liver function tests 30% above the upper limit of normal;
- •have an active gynecologic or systemic infection;
Outcomes
Primary Outcomes
Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment
Time Frame: Baseline and 7 days
Number of participants with decreased fibroid perfusion from baseline at 7 days post treatment of women with leiomyomata by UAE - Decreased Fibroid Perfusion Fibroid perfusion indicative of blood flowing to the fibroid at baseline and 7 days after embolization was determined using MRI.
Change in Fibroid Perfusion From Baseline at 28 Days Post Treatment of Women With Leiomyomata by UAE
Time Frame: Baseline and 28 days
Number of participants with decreased fibroid perfusion from baseline at 28 days post treatment of women with leiomyomata by UAE.
Number of Participants With Serious Adverse Events
Time Frame: 28 days
Short-term safety of OCL 503 at 28 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events
Secondary Outcomes
- Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE(28 days)
- Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE(7 days)
- Inflammatory Response Assessed by Histology at 7 Days Post Treatment of Women With Leiomyomata by UAE(7 days)
- Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE(28 days)