MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

• Sponsor: InSightec (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00365989
• Collaborator: (none)
• Enrollment: 50
• Locations: 5
• Arm: 1
• Duration (Months): 22
• Patients Per Site: 10
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.

Condition or Disease	Intervention/Treatment	Phase
Uterine Leiomyoma; Uterine Fibroids	Device: ExAblate Enhanced Sonication	Phase 3

Detailed Description

Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. InSightec has developed an Enhanced Sonication (ES) technique for the ablation of these fibroids. This mode of tissue ablation has been added to the already FDA approved ExAblate system. The goal of this ES technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving ALL clinical features of the current commercially approved version.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ExAblate Enhanced Sonication Test Arm The intervention to be administered is ExAblate Enhanced Sonication. The purpose of this study is to examine the safety profile of the ExAblate Enhanced Sonication mode to insure that no new safety issues are introduced compared to the normal focused ultrasound mode.	Device: ExAblate Enhanced Sonication; Other Names: Magnetic Resonance guided Focused Ultrasound

Outcome Measures

Primary Outcome Measures

1. Number of Adverse Events [Within 1 month of treatment]

   The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.

Other Outcome Measures

1. Mean Enhanced Sonication Normalized Thermal Dose Volume [During treatment]

   The secondary end point of the study is to evaluate the mean normalized Enhanced Sonication thermal dose volume. Normalized dose volume is a function of the sonication dose volume divided by the energy transmitted measured from the the MR thermometry imaging.

2. Number of Participants With Adverse Events [Within 1 month of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Women age 18 or older, who present with symptomatic fibroids

2. Women who have given written informed consent

3. Women who are able and willing to attend all study visits.

4. Patient is pre or peri-menopausal (within 12 months of last menstrual period).

5. Able to communicate sensations during the ExAblate procedure.

6. Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).

7. Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

1. Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment

2. Patient who desire to become pregnant in the future.

3. Patients who are breast-feeding.

4. Patients with an active pelvic inflammatory disease (PID)

5. Active local or systemic infection

6. Metallic implants that are incompatible with MRI

7. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)

8. Severe claustrophobia that would prevent completion of procedure in the MR unit.

9. Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path.

10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.

11. Pedunculated fibroids.

12. Intrauterine device (IUD) anywhere in the treatment path

13. Undiagnosed vaginal bleeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California at San Diego	La Jolla	California	United States	92037
2	Lahey Clinic	Burlington	Massachusetts	United States	01805
3	KNI	Kalamazoo	Michigan	United States	49048
4	Cornell Vascular	New York	New York	United States	10022
5	Toronto General Hospital	Toronto	Ontario	Canada	MG5 2C4

Sponsors and Collaborators

• InSightec

Investigators

• Principal Investigator: Anne Roberts, M.D., University of California, San Diego
• Principal Investigator: Mark Shaman, M.D., KNI
• Principal Investigator: Robert Min, M.D., Cornell
• Principal Investigator: David Gianfelice, M.D., Toronto General Hospital
• Principal Investigator: George Holland, M.D., Lahey Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor web page

Publications

None provided.

• Responsible Party: InSightec
• ClinicalTrials.gov Identifier: NCT00365989
• Other Study ID Numbers: UF018
• First Posted: Aug 18, 2006
• Last Update Posted: Feb 5, 2019
• Last Verified: Dec 1, 2018

• Keywords provided by InSightec: Fibroids; leiomyoma; neoplasm; benign tumors
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

Participant Flow

Pre-assignment Detail	Out of the 83 subjects signing consent, 33 subjects failed additional study requirements and did not participate. Fifty (50) subjects were treated; 48 received enhanced sonications, 2 received only nominal sonications.

Arm/Group Title	Enhanced Sonication Test Arm
Arm/Group Description	ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
Period Title: Overall Study
STARTED	50
COMPLETED	48
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Enhanced Sonication Test Arm
Arm/Group Description	ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
Overall Participants	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (5.4)
Sex: Female, Male (Count of Participants)
Female	48 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	5 10.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 6.3%
White	40 83.3%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Canada	11 22.9%
United States	37 77.1%

Outcome Measures

1. Primary Outcome

Title	Number of Adverse Events
Description	The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.
Time Frame	Within 1 month of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Sonication Test Arm
Arm/Group Description	ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
Measure Participants	48
Total Adverse Events	77
Mild/Moderate Adverse Events	75

2. Other Pre-specified Outcome

Title	Mean Enhanced Sonication Normalized Thermal Dose Volume
Description	The secondary end point of the study is to evaluate the mean normalized Enhanced Sonication thermal dose volume. Normalized dose volume is a function of the sonication dose volume divided by the energy transmitted measured from the the MR thermometry imaging.
Time Frame	During treatment

Outcome Measure Data

Analysis Population Description

Of the 50 subjects treated, 39 were included in the thermal analysis per the protocol. Of the 11 subjects not eligible, 8 were not treated with at least 30% enhanced sonications. Three subjects received enhanced sonications at tissue depths greater that 70 mm from the skin line.

Arm/Group Title	Enhanced Sonication Test Arm
Arm/Group Description	ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
Measure Participants	39
Mean (Standard Deviation) [cc/KJ/sonication]	0.67 (0.35)

3. Other Pre-specified Outcome

Title	Number of Participants With Adverse Events
Time Frame	Within 1 month of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ExAblate Enhanced Sonication Test Arm
Arm/Group Description	The intervention to be administered is ExAblate Enhanced Sonication. The purpose of this study is to examine the safety profile of the ExAblate Enhanced Sonication mode to insure that no new safety issues are introduced compared to the normal focused ultrasound mode. ExAblate Enhanced Sonication
Measure Participants	48
Subjects with SAE reported	0 0%
Subjects with no AEs reported	13 27.1%
Subjects reporting AEs	35 72.9%
Subject deaths	0 0%

Adverse Events

Arm/Group Title	Enhanced Sonication Test Arm
Arm/Group Description	ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
All Cause Mortality
	Enhanced Sonication Test Arm
	Affected / at Risk (%)	# Events
Total	0/48 (0%)
Serious Adverse Events
	Enhanced Sonication Test Arm
	Affected / at Risk (%)	# Events
Total	0/48 (0%)
Other (Not Including Serious) Adverse Events
	Enhanced Sonication Test Arm
	Affected / at Risk (%)	# Events
Total	35/48 (72.9%)
Gastrointestinal disorders
Gastrointestinal	5/48 (10.4%)
General disorders
All Pain/Discomfort	32/48 (66.7%)
Fever	1/48 (2.1%)
Dental	1/48 (2.1%)
Dizziness	1/48 (2.1%)
Nervous system disorders
Migraine	1/48 (2.1%)
Renal and urinary disorders
Urinary tract infection	5/48 (10.4%)
Urinary frequency	1/48 (2.1%)
Dysuria	1/48 (2.1%)
Incontinence	1/48 (2.1%)
Reproductive system and breast disorders
Abnormal Vaginal Discharge	2/2 (100%)
Heavy menses	1/48 (2.1%)
Abdominal cramping	1/48 (2.1%)
Skin and subcutaneous tissue disorders
Skin burn	1/48 (2.1%)
Edema	1/48 (2.1%)
IV bruise/numbness	1/48 (2.1%)
Rash	1/48 (2.1%)
Surgical and medical procedures
Leg pain - sonication related	13/48 (27.1%)
Abdominal pain - sonication related	7/48 (14.6%)
Back pain - sonication related	7/48 (14.6%)
Skin pain - sonication related	6/48 (12.5%)
Pain - sonication related	2/48 (4.2%)
Vascular disorders
Thrombophlebitis	1/48 (2.1%)

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.