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

• Sponsor: IMBiotechnologies Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02410018
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leiomyomata	Device: OCL 503 (uterine artery embolization)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Serious Adverse Events [7 days]

   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

2. Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment [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.

3. Number of Participants With Serious Adverse Events [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

4. Change in Fibroid Perfusion From Baseline at 28 Days Post Treatment of Women With Leiomyomata by UAE [Baseline and 28 days]

   Number of participants with decreased fibroid perfusion from baseline at 28 days post treatment of women with leiomyomata by UAE.

Secondary Outcome Measures

1. Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE [7 days]

   Tissue necrosis assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Fibroid necrosis observed

2. Inflammatory Response Assessed by Histology 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 - Perivascular inflammation - Low Grade

3. Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE [28 days]

   Tissue necrosis assessed by histology graded scale at 28 days post treatment of women with leiomyomata by UAE - Fibroid Necrosis

4. Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE [28 days]

   Inflammatory response assessed by histology at 28 days post treatment of women with leiomyomata by UAE - Perivascular Low Grade

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Albany Medical Center	Albany	New York	United States	12208

Sponsors and Collaborators

• IMBiotechnologies Ltd.

Investigators

• Principal Investigator: Gary Siskin, MD, Albany Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IMBiotechnologies Ltd.
• ClinicalTrials.gov Identifier: NCT02410018
• Other Study ID Numbers: OCL503-P1-UFE-01
• First Posted: Apr 7, 2015
• Last Update Posted: Dec 5, 2018
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

Participant Flow

Arm/Group Title	Cohort 1 - Uterine Artery Embolization	Cohort 2 - Uterine Artery Embolization
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Period Title: Overall Study
STARTED	2	1
COMPLETED	2	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Cohort 1 - Uterine Artery Embolization	Cohort 2 - Uterine Artery Embolization	Total
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Total of all reporting groups
Overall Participants	2	1	3
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	1 100%	3 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	2 100%	1 100%	3 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%	1 100%	3 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Serious Adverse Events
Description	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
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1 - Uterine Artery Embolization	Cohort 2 - Uterine Artery Embolization
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Measure Participants	2	1
Count of Participants [Participants]	0 0%	0 0%

2. Primary Outcome

Title	Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment
Description	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.
Time Frame	Baseline and 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1 - Uterine Artery Embolization	Cohort 2 - Uterine Artery Embolization
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Measure Participants	2	1
Count of Participants [Participants]	2 100%	1 100%

3. Primary Outcome

Title	Number of Participants With Serious Adverse Events
Description	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
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1 - Uterine Artery Embolization	Cohort 2 - Uterine Artery Embolization
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Measure Participants	2	1
Count of Participants [Participants]	0 0%	0 0%

4. Primary Outcome

Title	Change in Fibroid Perfusion From Baseline at 28 Days Post Treatment of Women With Leiomyomata by UAE
Description	Number of participants with decreased fibroid perfusion from baseline at 28 days post treatment of women with leiomyomata by UAE.
Time Frame	Baseline and 28 days

Outcome Measure Data

Analysis Population Description

Decrease in fibroid perfusion

Arm/Group Title	Cohort 1 - Uterine Artery Embolization	Cohort 2 - Uterine Artery Embolization
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Measure Participants	0	1
Count of Participants [Participants]	0 0%	1 100%

5. Secondary Outcome

Title	Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE
Description	Tissue necrosis assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Fibroid necrosis observed
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

Histological assessment of uterine tissue was conducted for Cohort 1 at 7-days, post-embolization. Histological assessment of uterine tissue was conducted for Cohort 2 at 28-days, post-embolization.

Arm/Group Title	Cohort 1 - Uterine Artery Embolization	Cohort 2 - Uterine Artery Embolization
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Measure Participants	2	1
Count of Participants [Participants]	2 100%	0 0%

6. Secondary Outcome

Title	Inflammatory Response Assessed by Histology at 7 Days Post Treatment of Women With Leiomyomata by UAE
Description	Inflammatory response assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Perivascular inflammation - Low Grade
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

Inflammatory response for Cohort 1 was assessed at 7-days, post-embolization. Inflammatory response for Cohort-2 was assessed at 28-days, post-embolization.

Arm/Group Title	Cohort 1 - Uterine Artery Embolization	Cohort 2 - Uterine Artery Embolization
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Measure Participants	2	1
Count of Participants [Participants]	2 100%	0 0%

7. Secondary Outcome

Title	Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE
Description	Tissue necrosis assessed by histology graded scale at 28 days post treatment of women with leiomyomata by UAE - Fibroid Necrosis
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Histological assessment of uterine tissue was conducted at 7-days for Cohort 1 and 28-days for Cohort 2, post-embolization.

Arm/Group Title	Cohort 1 - Uterine Artery Embolization	Cohort 2 - Uterine Artery Embolization
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Measure Participants	2	1
Count of Participants [Participants]	0 0%	1 100%

8. Secondary Outcome

Title	Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE
Description	Inflammatory response assessed by histology at 28 days post treatment of women with leiomyomata by UAE - Perivascular Low Grade
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Inflammatory response was conducted at 7-days post-embolization for Cohort 1 and 28-days for Cohort 2, post-embolization.

Arm/Group Title	Cohort 1 - Uterine Artery Embolization	Cohort 2 - Uterine Artery Embolization
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Measure Participants	2	1
Count of Participants [Participants]	0 0%	1 100%

Adverse Events

Time Frame	Day 0 through 28 days.
Arm/Group Title	Cohort 1 - Uterine Artery Embolization		Cohort 2 - Uterine Artery Embolization
Arm/Group Description	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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.		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. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
All Cause Mortality
	Cohort 1 - Uterine Artery Embolization		Cohort 2 - Uterine Artery Embolization
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Serious Adverse Events
	Cohort 1 - Uterine Artery Embolization		Cohort 2 - Uterine Artery Embolization
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Reproductive system and breast disorders
Fibroid expulsion	0/2 (0%)	0	0/1 (0%)	0
Other (Not Including Serious) Adverse Events
	Cohort 1 - Uterine Artery Embolization		Cohort 2 - Uterine Artery Embolization
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		1/1 (100%)
Investigations
Post-embolization Syndrome	2/2 (100%)	2	1/1 (100%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.