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

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

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.

Study Overview

• Status: Completed
• Conditions: Leiomyomata
• Intervention / Treatment: Device: OCL 503 (uterine artery embolization)

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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;
• have renal dysfunction as defined by a serum creatinine > 1.5 mg/dL
• have a history of gynecologic malignancy;
• have had a documented anaphylactic reaction to a drug or anesthetic, or an allergic reaction to iodine contrast media not controlled by antihistamines or steroids;
• have received other investigational drugs or who have had experimental therapy within the past four weeks or are participating in any other concurrent experimental therapy;
• have a uterine volume < 250 mL or approximately > 24 weeks gestation;
• have known endometrial hyperplasia, adenomyosis, or pelvic inflammatory disease;
• have abnormal coagulation profiles;
• are allergic to bovine collagen;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1 - Uterine Artery Embolization; Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis.	Device: OCL 503 (uterine artery embolization); Transcatheter embolization of the uterine artery(ies) using an embolic agent.
EXPERIMENTAL: Cohort 2 - Uterine Artery Embolization; Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis.	Device: OCL 503 (uterine artery embolization); Transcatheter embolization of the uterine artery(ies) using an embolic agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious Adverse Events	Short-term safety of OCL 503 at 7 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events	7 days
Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment	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.	Baseline and 7 days
Number of Participants With Serious Adverse Events	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	28 days
Change in Fibroid Perfusion From Baseline at 28 Days Post Treatment of Women With Leiomyomata by UAE	Number of participants with decreased fibroid perfusion from baseline at 28 days post treatment of women with leiomyomata by UAE.	Baseline and 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE	Tissue necrosis assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Fibroid necrosis observed	7 days
Inflammatory Response Assessed by Histology at 7 Days Post Treatment of Women With Leiomyomata by UAE	Inflammatory response assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Perivascular inflammation - Low Grade	7 days
Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE	Tissue necrosis assessed by histology graded scale at 28 days post treatment of women with leiomyomata by UAE - Fibroid Necrosis	28 days
Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE	Inflammatory response assessed by histology at 28 days post treatment of women with leiomyomata by UAE - Perivascular Low Grade	28 days

Collaborators and Investigators

• Sponsor: IMBiotechnologies Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: March 6, 2015
• First Submitted That Met QC Criteria: April 6, 2015
• First Posted (ESTIMATE): April 7, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: OCL503-P1-UFE-01