Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Up to 50% of the prostate gland will be treated. Treatment will include the Index lesion which is visible on MRI + tumor free margins of 3-mm; tumor free margins will not extend beyond the posterior aspect of the prostate capsule.

Urethral and bilateral neurovascular bundle preservation will be preferred whenever clinically justified.

Additional foci in the same hemisphere that are confirmed by biopsy and are \< Gleason Score 7 (up to 3+4 or 4+3) or suspected to be positive for malignancy based on multi parametric-MRI) will also be included in the treated volume, providing total treatment volume does not exceed 50% of the gland.

ExAblate treatment of prostate cancer less than or equal to Grade 7

ExAblate MRgFUS

Sangeet Ghai, MD

This study is intended to show that ExAblate™ MRgFUS is a safe procedure that can significantly postpone or eliminate the need of patients with organ confined intermediate risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation therapy) for their disease.

This study will evaluate the proportion of patients with organ-confined intermediate risk prostate cancer (OC-IRPC) undergoing focal ExAblate™ MRgFUS prostate treatment that will be free of clinically significant PCa which requires definitive treatment at 2 years after completion of their ExAblate™ treatment and to demonstrate the safety of focal ExAblate™ MRgFUS treatment.

Clinically significant PCa requiring definitive treatment is defined as pathology findings from whole-gland, imaging-guided, extended mapping biopsy of Gleason Score (GS) \> 7

The primary efficacy endpoint in this trial, measured at 24 months with whole-gland extended imaging-guided mapping biopsy, is Response scored dichotomously for each subject as follows:

* Response = 0 ("Failure"): Positive mapping biopsy defined as Gleason Score \> 7 (indicating definitive treatment) in any part of their prostate gland
* Response = 1 ("Success"): Negative mapping biopsy defined as Gleason Score \< 7.

Safety of ExAblate™ treatment will be determined by evaluation of the incidence and severity of device related complications from the first treatment day visit throughout entire follow-up duration.

All adverse events will be captured and recorded. However, the safety of the ExAblate™ treatment will be defined by the incidence and severity of treatment or device related adverse events, grades III - V (CTCAE version 4.03; 2010-06-14).

Secondary Effectiveness Outcomes:

1. % of patients with negative 5-month follow-up biopsy results in the treated part of the prostate
2. Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified intervals.

   1. Urinary symptoms - IPSS
   2. Urinary continence - ICIQ-UI-SF
   3. Sexual function - IIEF-15
3. PSA levels and post-treatment PSA kinetics will also be assessed

Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer

Focal ExAblate™ MR-Guided Focused Ultrasound (MRgFUS) Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer (OC-IRPC): Evaluation of Safety and Effectiveness

Response will be based on mapping biopsy defined by Gleason 7 Score in any part of the prostate gland

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

% of patients with negative 5-month follow-up biopsy results in the treated part of the prostate

Treatment effect on patients' Quality of Life (QoL), i.e., urinary symptoms

Treatment effect on patients' Quality of Life, (QoL), i.e., urinary continence

Treatment effect on patients' Quality of Life, (QoL), i.e.,sexual function

PSA levels and post-treatment PSA kinetics will be assessed

InSightec

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

100% ablation of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor

Hans Kolberg, MD

The goal of this prospective, non-randomized, single-arm, multi site, international study is to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the ablation of breast cancer and of MRI.

The goal of MRgFUS ablation of breast cancer is to plan and ablate the entire tumor volume in a treatable and device accessible location.

In this international, non-randomized, single-arm study, a total of 200 patients with a positive diagnosis of invasive breast cancer with a scheduled surgical resection will be enrolled into the trial. Eligible participants will be evaluated and treated with ExAblate breast ablation prior to their planned definitive surgical treatment. After the 10 to 21 days post ExAblate therapy, study participants will have another contrast-enhanced MR imaging examination. Their planned tumor excision will then be completed no later than 14 days from the contrast-enhanced, post ExAblate procedure MR imaging examination. Additionally, the end points of the study will be compared against the CORE Pathology Lab results.

Study of ExAblate Focused Ultrasound Ablation of Breast Cancer

Study of ExAblate Focused Ultrasound Ablation of Breast Cancer Under MR Guidance (MRgFUS) and MRI Evaluation of Ablation

To evaluate the incidence and severity of the ExAblate MRgFUS device-related complications to establish the safety profile of the ExAblate ablation of breast cancer visible on contrast-enhanced MRI with 5-10 mm margins around the primary tumor

To estimate the effectiveness of ExAblate MRgFUS to ablate 100% of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor.

To estimate the sensitivity of post-ablation MRI in identifying residual disease following ablation.

Symptoms and General Pathology

Musculoskeletal Diseases

Neoplasm Metastasis

Pain

Bone Neoplasms

Bone Diseases

Focused Ultrasound Surgery delivered by ExAblate MRgFUS

The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain.

As part of the PMA # P110039 review process and approval, InSightec was requested to conduct a post-approval study. Patients will be treated following the approved commercial treatment guidelines.

For this study, participating sites will use the ExAblate device for the administration of the ExAblate treatment. This study will be performed on either 1.5T or 3T MR scanners.

For this study, a total of 70 patients meeting the approved commercial guidelines will be enrolled and treated with the ExAblate system at from 7 to 10 sites. The proportion of responders is expected to be at least 30% greater than the proportion of subjects experiencing pain progression (i.e., 60% vs. 30%). Additionally, at the 3 month visit, an analysis of both the safety and efficacy profiles will be compared to the original PMA pivotal study group.

A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

Patient pain intensity on an 11-point Numerical Rating Scale from 0 to 10 in which 0 is no pain and 10 is the worst pain you can imagine. The NRS was administered pre-treatment and post-treatment. The trajectory of change was presented graphically.

The BPI-QOL questionnaire is designed to show the severity and interference of pain in the lives of patients. This is a 7-item questionnaire that asks respondents the extent to which pain interferes with their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life using a 0-10 numerical rating scale in which 0 represents 'does not interfere' and 10 indicates 'completely interferes'. Responses to the 7 items are averaged to form the pain interference scale score. Thus, the minimum possible is 0 and the maximum possible is 10 points. Lower scores are better, showing less interference in daily activities while higher scores show more interference and hence worse outcomes.

The statistical hypothesis is that the proportion of responders will be significantly greater than the proportion of subjects experiencing pain progression (worsened pain or increased pain medications usage). Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), subjects were rated as a Responder or as having Pain Progression. A responder is defined as a subject with a reduction in NRS worst score from baseline of two (2) or more points, and no increase in pain medication use. Pain Progression was increased pain of two (2) or more points.

All device or procedure related adverse events were collected

Focused Ultrasound Surgery delivered by ExAblate MRgFUS

ExAblate MRgFUS: Focused Ultrasound Ablation

ExAblate Test Arm

Age, Continuous

Sex: Female, Male

White

Hispanic

Black

Asian

Race/Ethnicity, Customized

United States

Region of Enrollment

The Numerical Rating Scale (NRS) for pain is an 11 point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Low scores (0) are better and high scales (10) are worse.

Numerical Rating Scale

Nadir Alikacem, VP Global Regulated Clinical Affairs & CRO

The alternative hypothesis test was that the proportion of Responders would be greater than the proportion of subjects experiencing pain progression. This PAS was powered to enroll 70 subjects based on the pivotal trial proportion of 18:8 (Responders:Pain progression). The study was closed at an enrollment of 32 subjects.

The analysis was based on 31 treated subjects that completed at least one follow up visit; 23 out of 31 subjects were either Responders or had Pain Progression. Eight subjects reported no change in pain.

Proportion of Responders

Baseline

1 Month Visit

2 Month Visit

3 Month Visit

There were 31 subjects treated that provided a baseline score and a final follow-up score.

Numerical Rating Scale (NRS) for Pain Score

One out of the 31 treated subjects did not complete the Baseline QoL (pain interference assessment and could not be included in the QoL analysis).

Quality of Life (QOL) as Measured by Change in Brief Pain Inventory - Interference (BPI) From Baseline

Overall Study

Patients undergoing simulated ExAblate MRgFUS device use

ExAblate MRgFUS for prostate cancer

Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.

The objective of this study is to evaluate safety, compatibility and imaging quality of the ExAblate MRgFUS system for prostate cancer, under simulated use conditions. No acoustic energy will be delivered and no focused ultrasound therapy will be performed. This is an imaging only study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer	NCT02968784	Prostate Cancer	ExAblate MRgFUS	50 Years -	InSightec
Study of ExAblate Focused Ultrasound Ablation of Breast Cancer	NCT01620359	Breast Cancer	ExAblate MRgFUS	18 Years -	InSightec
A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain	NCT01833806	Bone Metastasis	ExAblate MRgFUS	18 Years -	InSightec
A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain	NCT01833806	Bone Metastasis	ExAblate MRgFUS	18 Years -	InSightec
Safety Evaluation of ExAblate MRgFUS for Prostate Cancer	NCT00811265	Prostate Cancer	ExAblate MRgFUS...	- 75 Years	InSightec

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