Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Rare Diseases

Breast Neoplasms

Prostatic Neoplasms

Osteosarcoma

Neoplasm Metastasis

Lung Neoplasms

Cancer Pain

Pain

Bone Neoplasms

Neoplastic Processes

ExAblate 2100 ablation for the treatment of painful bone metastases.

ExAblate 2100

A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.

Bone is the third most common organ involved by metastatic disease behind lung and liver \[6\]. 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.

Current treatments for patients with bone metastases are primarily palliative and include localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphonates although the primary goal of the use of these therapies are often to address the disease itself), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases \[8\]. Currently, an off label use of Cryoablation techniques are being tested as another alternative for bone Mets palliation. 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

Treatment with external beam radiation therapy (EBRT) is the standard of care for patients with localized bone pain, and results in the palliation of pain for many of these patients. Twenty to 30% of patients treated with radiation therapy do not experience pain relief \[9-13\]. Re-treatment rates are generally reported in the range of 10-25%. Many patients with relapsed pain or poor response to initial radiation may be lost to follow up or may not be referred back to oncologists for consideration of re-radiation. In addition to relapse and re-treatment, there is an increased risk of pathologic fracture in the peri-radiation period. The fracture rate reported in radiation studies is generally in the range of 1% to 8%. The hyperemic response weakens the adjacent bone and increases the risk of spontaneous fracture. Furthermore, patients who have recurrent pain at a site previously irradiated may not be eligible for further radiation therapy secondary to limitations in normal tissue tolerance. Hesitation on the part of physicians to use a larger dose may be related to increased long-term toxicity. Larger radiation dose produces a greater risk of complications such as fibrosis of normal soft tissue, which can cause a decrement in the quality of life in cases of life expectancy longer than 6 months. There may also be a greater incidence of acute side effects of nausea and vomiting if the treatment field includes the stomach. The percent of patients experiencing vomiting following EBRT ranges from about 5% to 30%.

A palliative treatment for painful bone metastases that is non-invasive, without long-term toxicity and having minimal complications would be a useful tool for treating physicians and also a beneficial option for patients suffering from painful bone metastases. Results of preliminary studies indicate that ExAblate treatment of painful bone metastases may be a beneficial treatment option \[14, 15\]. The ExAblate system is a non-invasive thermal ablation device used in the coagulation of various types of soft tissue. The ExAblate system has the potential to achieve the first three of the four previously mentioned goals in the treatment of bone tumors; namely pain relief, preservation and restoration of functional levels and local tumor control \[11\]. The ExAblate system used in the present study is a technological advance over the ExAblate 2000 fixed transducer system in terms of flexibility of use and reduction of positioning related pain to the patients. The ExAblate system used in this study conforms to the patient's body shape at the location of the bone mets location.

ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain

A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System

Adverse effects outcomes are reported in the adverse events module.

Efficacy was evaluated by change in Numerical Rating Scale (NRS) pain scores at 3 months post treatment The NRS is an 11 point scale (0-10) with 0 as no pain and 10 as the worst pain. Larger numbers in score change from baseline indicate improvement (decrease) in pain. Two points improvement has been reported as a clinically meaningful.

Quality of life was evaluated using average change from baseline at 3 Months using the Pain Interference section of the Brief Pain Inventory (BPI-Pain Interference). Larger change from Baseline numbers indicate improved function. Pain Interference is the mean of seven questions scored on an 11-point scale of 0 (does not interfere) to 10 (completely interferes). A positive change from Baseline (higher values) at the 3 Month visit indicates improvement or a reduction in pain interference

InSightec

ExAblate 2100 ablation for the treatment of painful bone metastases.

ExAblate 2100: Conformal Bone System

ExAblate 2100 Treatment

Age, Continuous

Sex: Female, Male

Hispanic

Black

White

Asian

Pacific Islander

The baseline characteristics were tabulated for the treated subjects.

Race/Ethnicity, Customized

United States

Region of Enrollment

The study was terminated early leading to small numbers of subjects analyzed. The study was designed to enroll 50 subjects. Enrollment was terminated after enrolling 17 subjects.

Nadir Alikacem

Number of Adverse Device Effects

Change in NRS Pain Scores From Baseline at 3 Months

Change Brief Pain Inventory - Pain Interference From Baseline at 3 Months

Overall Study

Nervous System Diseases

Behaviors and Mental Disorders

Hemorrhage

Leiomyoma

Myofibroma

Pelvic Pain

Neurologic Manifestations

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Quality of Life

Exablate 2100

Myomectomy

Wady Gedroyc, Prof.

The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids.

Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy.

All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment.

Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.

Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids

A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids

Safety will be evaluated by recording and assessing the incidence and severity of major adverse events from treatment through the 3 years follow-up period.

Comparison between ExAblate treatment and non-Hysteroscopic Myomectomy in terms of treated patients who did not undergo another interventional treatment for recurrence of uterine fibroid symptoms at up to 36 months (3 years).

1. Post treatment change in patient's quality of life
2. Post treatment change in pelvic pain
3. Post treatment Change in bleeding
4. Post treatment recovery time

Bone Diseases

Neoplasms, Bone Tissue

Sarcoma

Soft Tissue Sarcoma

The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. The treated patients will be followed for 3-Months post their last treatment, patients with the standard contraindications to MRI examination, such as implanted metal devices (pacemakers, etc.), will be excluded.

Bone is the third most common organ involved by metastatic disease behind lung and liver \[6\]. 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.

Current treatments for patients with bone metastases are primarily palliative and include localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphonates although the primary goal of the use of these therapies are often to address the disease itself), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases \[8\]. Currently, an off label use of Cryoablation techniques are being tested as another alternative for bone Mets palliation. 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

Treatment with external beam radiation therapy (EBRT) is the standard of care for patients with localized bone pain, and results in the palliation of pain for many of these patients. Twenty to 30% of patients treated with radiation therapy do not experience pain relief \[9-13\]. Re-treatment rates are generally reported in the range of 10-25%. Many patients with relapsed pain or poor response to initial radiation may be lost to follow up or may not be referred back to oncologists for consideration of re-radiation. In addition to relapse and re-treatment, there is an increased risk of pathologic fracture in the peri-radiation period. The fracture rate reported in radiation studies is generally in the range of 1% to 8%. The hyperemic response weakens the adjacent bone and increases the risk of spontaneous fracture. Furthermore, patients who have recurrent pain at a site previously irradiated may not be eligible for further radiation therapy secondary to limitations in normal tissue tolerance. Hesitation on the part of physicians to use a larger dose may be related to increased long-term toxicity. Larger radiation dose produces a greater risk of complications such as fibrosis of normal soft tissue, which can cause a decrement in the quality of life in cases of life expectancy longer than 6 months. There may also be a greater incidence of acute side effects of nausea and vomiting if the treatment field includes the stomach. The percent of patients experiencing vomiting following EBRT ranges from about 5% to 30%.

A palliative treatment for painful bone metastases that is non-invasive, without long-term toxicity and having minimal complications would be a useful tool for treating physicians and also a beneficial option for patients suffering from painful bone metastases. Results of preliminary studies indicate that ExAblate treatment of painful bone metastases may be a beneficial treatment option \[14, 15\]. The ExAblate system is a non-invasive thermal ablation device used in the coagulation of various types of soft tissue. The ExAblate system has the potential to achieve the first three of the four previously mentioned goals in the treatment of bone tumors; namely pain relief, preservation and restoration of functional levels and local tumor control \[11\]. The ExAblate system used in the present study is a technological advance over the ExAblate 2000 fixed transducer system in terms of flexibility of use and reduction of positioning related pain to the patients. The ExAblate system used in this study conforms to the patient's body shape at the location of the bone mets location

Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System

Phase II Study to Evaluate the Safety and Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System

Evaluate incidence and severity of adverse events associated with ExAblate MRgFUS ExAblate Conformal system used in the palliation of pain due to metastatic bone tumors

Level of pain relief (measured by Pain Scale)

Improved quality of life (measured by questionnaire)

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

The pancreatic tumor will be ablated with magnetic resonance guided focused ultrasound (MRgFUS).

A non-invasive thermal ablation device fully integrated with an MR imaging system

Pejman Ghanouni

The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of advanced stage pancreatic adenocarcinoma.

Primary Objective: The primary endpoints for this study will be 1) feasibility of ablation and 2) safety of ablation.

Secondary Objective: 1.)Pain reduction after ablation. 2.) Evidence of inflammation at ablation site based on histology, or in blood after ablation

Magnetic Resonance Guided High Intensity Focused Ultrasound in Advanced Pancreatic Adenocarcinoma Treatment

A Phase I Study of Magnetic Resonance Guided High Intensity Focused Ultrasound for Treatment of Advanced Pancreatic Adenocarcinoma

Feasibility of ablation, as measured by the number of patients with acceptable ablation percentage. Acceptable ablation percentage is defined as ≥50% of the targeted volume appearing ablated on post-treatment imaging. Ablation will be deemed feasible if at least seven of the ten patients have an acceptable ablation percentage

Safety of ablation, as measured by the total frequency and severity of adverse events. Adverse events will be categorized and grade for severity according to the Common Terminology Criteria for Adverse Events, Version 5.0. Ablation will be deemed safe if there are no treatment-related serious adverse events, and no more than five moderate or mild treatment-related adverse events, among the ten patients during follow up.

Reduction in pain level, as measured by:

a. a decline in pain score after one week of at least 2 points, or a pain score \< 4 out of 10, as assessed by the Brief Pain Inventory. Ablation will be deemed pain reducing if at least five of the ten patients have pain reduction.

Reduction in pain level will be measured by a decline after one week in morphine equivalent daily dose (MEDD) of 25%. Ablation will be deemed pain reducing if at least five of the ten patients have pain reduction.

Evidence of ablation-induced inflammation, defined as post-ablation increases in histologic and/or blood measures of inflammation markers, as measured by either:

1. an increase in tumor infiltrating CD8+ T cells
2. a decrease in immune suppressive cells (Tregs, macrophages) in the tumor
3. an increase in immune activation signatures (including interferon gamma) in the tumor as measured by RNAseq
4. a change in immune profile in the circulating immune cells (PBMCs) to reflect an activated immune response (e.g. activated T or B cells, reduction in immune suppressive cells or cytokines) Ablation will be deemed inflammation-inducing if at least five of the ten patients show at least a 50% increase in inflammation on at least 2 of the 4 markers

Stanford University

The first magnetic resonance-guided focused ultrasound (MRgFUS) treatment of uterine fibroid using the ExAblate 2000 system was performed in 2001. Since then, more than 5000 treatments were done in more than 60 different hospitals around the world. The experience accumulated in this novel treatment was collected by InSightec and implemented into software and hardware updates, clinical tips and guidelines, all aimed to improve the clinical results and their durability, while maintaining a high level of safety.

Based on extensive clinical experience and our internal research and development effort goals toward continuous improvement in ExAblate treatment safety and performance, limited changes have been made to the current ExAblate system. This modified ExAblate system version is designated as the ExAblate 2100 UF V2 system.

The modifications are believed to improve system's friendliness to the user, without introducing new risks or other issues of safety of the device, and should not have any negative impact on the safety or technical efficacy of the treatments for patients.

A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids

Safety of ExAblate 2100 UF V2 will be determined by an evaluation of the incidence and severity of device- and procedure-related adverse events from the first visit through 1-month post-treatment.

Efficacy will be evaluated by comparing the Non-perfused volume obtained from this study with that of the dataset supporting PMA approval using descriptive statistics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain	NCT00981578	Bone Metastases	ExAblate 2100	18 Years -	InSightec
Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids	NCT01328067	Uterine Fibroid... Bleeding Pelvic Pain	Exablate 2100 Myomectomy	18 Years - 50 Years	InSightec
Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System	NCT01085565	Bone Cancer Bone Metastases Pain	ExAblate 2100	18 Years -	InSightec
Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids	NCT01328067	Uterine Fibroid... Bleeding Pelvic Pain	Exablate 2100 Myomectomy	18 Years - 50 Years	InSightec
Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids	NCT01328067	Uterine Fibroid... Bleeding Pelvic Pain	Exablate 2100 Myomectomy	18 Years - 50 Years	InSightec
Magnetic Resonance Guided High Intensity Focused Ultrasound in Advanced Pancreatic Adenocarcinoma Treatment	NCT04298242	Pancreatic Aden...	ExAblate 2100	18 Years -	Stanford University
A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids	NCT01092988	Uterine Fibroid... Bleeding Pain	Exablate 2100	18 Years -	InSightec

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