Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Infertility

Myofibroma

Genital Diseases

Urogenital Diseases

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Non-invasive procedure for fertility enhancement (i.e., ExAblate treatment)

Invasive surgical procedure for fertility enhancement (i.e., myomectomy)

Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation

ExAblate 2000

Invasive surgical procedure for fibroid removal

Myomectomy

The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained infertility.

Uterine fibroids are fairly common in women of child-bearing age. An evidence based review supported removing fibroids that distort the uterine cavity to increase pregnancy rates and decrease the rates of miscarriage. Some fibroids can be removed hysteroscopically which is minimally invasive, with low morbidity. However, removal of fibroids within the uterine wall require more invasive surgical procedures (e.g., myomectomy), with increasing morbidity risks including, but not limited to, infection, blood loss and postoperative uterine adhesions.

ExAblate is approved by FDA for the treatment of uterine fibroids; however, its use in patients seeking pregnancy is considered experimental. Accumulated evidence suggests there are no significant complications from the procedure in women seeking pregnancy as with existing fibroid therapies; however, these data are based on a small number of patients. This study will evaluate fertility enhancement following ExAblate treatment or myomectomy, in women with unexplained infertility and who have non-hysteroscopically resectable uterine fibroids.

ExAblate Treatment of Uterine Fibroids for Fertility Enhancement

A Randomized Study to Evaluate the Effectiveness and Safety of ExAblate Surgery Compared With Myomectomy for the Enhancement of Fertility Following Treatment of Uterine Fibroids in Women Seeking Pregnancy

InSightec

All patients who received at least 10 therepeutic sonications with the ExAblate 2000 Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation.

ExAblate Treatment:

All patients who had more than 15 grams of fibroid tissue excised.

Myomectomy Treatment:

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Study was terminated due to lack of enrollment

enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Nadir Alikacem

Live Birth Rate

Pregnancy Rate

Term Delivery Rate

Miscarriage Rate

Time to Conception

C-Section Rate

Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)

Center for Epidemiologic Studies Depression Scale (CES-D)

Medical Outcomes Study 36-Item Short Form Survey

Health Care Costs

Overall Study

Treatment with the ExAblate 2000 system Version 4.1

Robert Min, M.D.

The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment.

Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.'

Background

General:

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. In general, these symptoms can be classified into two categories:

1. heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, substantial prolongation of menstrual periods compared with the patient's prior experience, or anemia.
2. pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in nocturia, difficulty voiding or compression of the ureters with hydronephrosis.

Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment itself.

ExAblate Device:

The InSightec ExAblate MR guided Focused Ultrasound Surgery (MRgFUS) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue. It has been evaluated in an earlier FDA international, multi-center study and found to be safe and effective for the treatment of uterine fibroids. ExAblate device received FDA approval in October 2004.

Prior Studies:

The ExAblate has been used for the treatment of uterine fibroids in 2 previous IDE protocols.

* Group A: This was the original Pivotal Study Group (IDE G020001 - Protocol UF002). These 109 patients were treated at 3 sites in the US and at 4 sites outside the US. There was a limitation on the allowable treatment volume and only a single treatment was permitted. Original follow-up was planned for 6 months. The study was later extended to include follow-up visits at 12, 24, and 36 months (UF009). Because of the gap between the initial study consent, and the re-consent for the long term follow-up there was a high dropout rate at the 12 month visit. Thirty-three US patients returned for the 12 months visit, and will continue to be followed for the 24 and 36 M visits.
* Group B: This was the Continued Access Study (IDE G020001 - Protocol UF005) where approximately 160 patients were treated at 3 sites in the US during the PMA review period. Treatment conditions were modified somewhat from the pivotal, including the addition of a second treatment session where necessary. The initial study was planned to include a long term follow-up of 12, 24 and 36 months (UF009).
* Group C: This group of 70 patients (UF14) will be treated post-PMA approval following the commercial treatment guidelines. The follow-up will include for visits at 12, 24 and 36 months. This group includes also another 20 patients who will be treated under this original IDE to validate the ExAblate system for use in a 3T MR scanner, as well as validating a new application SW (V4.1).

Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids

Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids

Adverse events outcomes are reported in the adverse events module.

Treatment with the ExAblate 2000 system Version 4.1

ExAblate 2000

ExAblate MRgFUS

not collected

Age, Customized

This study was closed to enrollment in 2005 due to obsolescence of device features. Only safety data on the 9 enrolled participants was reported.

Number and Type of Adverse Events

Number of Subjects With Adverse Events

Phyllis Gee, M.D.

Paul Curtis, M.D.

George Holland, M.D.

Dennis Sarti, M.D.

Fred Steinberg, M.D.

Elizabeth Stewart, M.D.

This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms.

After the PMA Panel, the sponsor was requested to conduct a post-approval study. The objective of this study is to gather additional data to evaluate the safety and long term effectiveness of focused ultrasound treatment, and to include a larger cohort of African-American patients. Patients will be treated following the approved commercial treatment guidelines.

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. In general, these symptoms can be classified into two categories:

1. heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, substantial prolongation of menstrual periods compared with the patient's prior experience, or anemia.
2. pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in nocturia, difficulty voiding or compression of the ureters with hydronephrosis.

Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment itself.

MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Rare Diseases

Prostatic Neoplasms

Osteosarcoma

Neoplasm Metastasis

Lung Neoplasms

Bone Neoplasms

Bone Diseases

Christine Chung, M.D.

David Gianfelice, M.D.

The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the treatment of metastatic bone tumors.

Bone is the third most common organ involved by metastasic disease behind lung and liver. In breast cancer, bone is the second most common site of metastatic spread, and 90% of patients dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize to bone most frequently, which reflects the high incidence of both these tumors, as well as their prolonged clinical courses.

Post cancer survival has increased with improvement in early detection and treatments. As a consequence, the number of patients developing metastatic bone disease during their lifetime has also increased. Patients with bone metastasis from breast cancer have an average 2-year survival from the time of presentation with their first bone lesion. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death.

Current treatments for patients with bone metastases are primarily palliative and include localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphanates), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described: 1) Pain relief, 2) Preservation and restoration of function, 3) Local tumor control, 4) Skeletal stabilization.

The study hypothesis is that MRgFUS is a safe and potentially effective non-invasive treatment for metastatic bone tumors with a low incidence of co-morbidity. Based on the result of this study the Sponsor will initiate a larger study in an effort to approve metastatic bone tumors as an indication for its MRgFUS ExAblate device.

MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors

Breast Neoplasms

Fibroadenoma

Neoplasms, Fibrous Tissue

Neoplasms, Glandular and Epithelial

Clare Tempany, M.D.

Mark DeLaurentis, M.D.

Hidemi Furusawa, M.D.

The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of \> 50% on palpation, and \>65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.

Many patients are now diagnosed with breast fibroadenomas. These are generally detected during breast self-exams, or annual physicals as a smooth, rubbery, oval/elliptical lump in the breast. These patients then go on to receive mammograms, sonograms and usually a core biopsy for the differential diagnosis of benign disease (fibroadenoma) vs breast cancer. Although fibroadenomas are benign, they can be of great concern to the patient because of their ability to mask the presence of other lumps in the breast, they can be painful, cause a physical deformity of the breast or have other symptoms. The current treatment is surgical excision. Surgical removal is invasive and may be cosmetically undesirable to some patients. It would be advantageous to develop a non-invasive ablative method for treatment of this disease. Measures of the clinical success of patients who elect surgical removal of fibroadenomas are generally subjective, and evaluated primarily by the patient (lack of palpable lesion, pain free, and an acceptable cosmetic result). A non-randomized study is proposed to allow for a more practical approach in subject recruitment. Analysis on safety and efficacy will be performed through the use of MRI evaluation and physical exams.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ExAblate Treatment of Uterine Fibroids for Fertility Enhancement	NCT00730886	Uterine Fibroid...	ExAblate 2000 Myomectomy	21 Years - 40 Years	InSightec
Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids	NCT00131365	Leiomyoma	ExAblate 2000	-	InSightec
ExAblate Treatment of Uterine Fibroids for Fertility Enhancement	NCT00730886	Uterine Fibroid...	ExAblate 2000 Myomectomy	21 Years - 40 Years	InSightec
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids	NCT00166270	Uterine Fibroid...	ExAblate 2000	18 Years -	InSightec
MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors	NCT00350233	Bone Metastases	ExAblate 2000	18 Years -	InSightec
MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas	NCT00147108	Breast Fibroade...	ExAblate 2000	18 Years -	InSightec
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids	NCT00166270	Uterine Fibroid...	ExAblate 2000	18 Years -	InSightec
MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas	NCT00147108	Breast Fibroade...	ExAblate 2000	18 Years -	InSightec
MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors	NCT00350233	Bone Metastases	ExAblate 2000	18 Years -	InSightec

Spots Global Cancer Trial Database for exablate 2000