Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors

A Feasibility Study to Evaluate the Safety and Effectiveness of ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound Treatment of Soft Tissue Tumors of the Extremities

The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) surgery in the treatment of soft tissue tumors of the extremities.

Study Overview

• Status: Terminated
• Conditions: Soft Tissue Neoplasms
• Intervention / Treatment: Device: MRgHIFU; Drug: Aspirin; Drug: Enoxaparin

Detailed Description

Given that the incidence of cancer increases with age, the number of elderly patients diagnosed and treated for soft tissue sarcomas (STS) will increase. The dilemma is that surgeons and medical oncologists may be hesitant to treat elderly patients in a comparably intensive manner as is used in the treatment of younger patients; factors such as decreased performance status, significant comorbidities, and disease natural history may erode enthusiasm for aggressive STS resection. To this end, a less invasive way of treating soft tissue tumors would be helpful in younger patients to minimize morbidity and in the elderly to provide less aggressive treatment options. The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue (5-10). The ExAblate combines a focused ultrasound surgery (FUS) delivery system and a conventional diagnostic 1.5 T or 3 T MRI scanner. It provides a real-time therapy planning algorithm, thermal dosimetry, and closed-loop therapy control.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

• ≥ 10 years of age.
• Benign or malignant soft tissue tumors of the extremities, flanks, pelvis, or shoulders requiring surgical intervention.
• Tumor must not have been treated previously with radiation.
• Targeted tumor(s) are accessible to the ExAblate device
• Targeted volume within the tumor is located deeper than 1 cm from the skin
• Targeted tumor is clearly visible by non-contrast magnetic resonance imaging (MRI)
• Karnofsky Performance Status > 60
• Normal platelet count and coagulation profile
• Glomerular filtration rate > 60 mL/min
• Able to safely undergo MRI exam and receive mild sedation for the treatment.
• Able to tolerate being in the MRI scanner for the duration of the study.
• Able and willing to give consent (or consent + assent where applicable), and able to attend all study visits.

EXCLUSION CRITERIA

• Previous radiation treatment to the tumor.
• Currently receiving dialysis.
• Acute medical condition (eg, pneumonia, sepsis) expected to hinder completion of the study

• Unstable cardiac status including:

  • Unstable angina pectoris on medication
  • Patients with documented myocardial infarction within six months of protocol entry
  • Congestive heart failure requiring medication (other than diuretic)
  • Patients on anti-arrhythmic drugs
• Severe hypertension (diastolic BP > 100 on medication)
• Contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, etc
• Severe hematologic, neurologic, or other uncontrolled disease
• Known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine)
• Known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease
• Pregnant and nursing
• Karnofsky Performance Score < 60
• Severe cerebrovascular disease [cardiovascular accident (CVA) within 6 months]
• Not able or not willing to tolerate the required prolonged stationary position during treatment (up to 5 hrs of total table time)
• Target volume in tumor is less than 1 cm from neurovascular bundles, major blood vessels, bowel, or bladder.

• Targeted tumors:

  • NOT visible by non-contrast MRI, OR
  • NOT accessible to ExAblate device
• Not a candidate for either regional anesthesia or mild sedation
• Not be participating in another trial testing other investigational agents or devices

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MRgHIFU; The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue. The treatment process begins with the physician acquiring a set of MR images, identifying 1+ target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours. The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment. The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated. About 100 individual sonications can be delivered over a 3-hour period to complete a treatment.

Device: MRgHIFU; The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue; Other Names: ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound; Drug: Aspirin; 325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment; Other Names: Ecotrin; Drug: Enoxaparin; 40 mg by subcutaneous (SC) administration, for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment; Other Names: Lovenox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Safety - Incidence of Any Device-related Adverse Events	Safety determined by evaluating for the incidence of any device-related adverse events. Patients will be assessed for pain and limb function, and by clinical examination before and after treatment to collect adverse events related to the treatment. Safety is reported as the total incidence of device-related adverse events.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Severity	Safety is further assessed by an evaluation of severity for the treatment-related adverse events, reported as the number of adverse events for each of the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades. CTCAE Severity: mild; moderate; severe; life-threatening; fatal	6 months
Percent Successful Tumor Ablation	In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice. The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed. Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume.	Up to 1 week

Collaborators and Investigators

• Sponsor: Pejman Ghanouni
• Investigators: Principal Investigator: Pejman Ghanouni, MD, PhD, Stanford University; Principal Investigator: Raffi Avedian, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 24, 2015
• Study Completion (Actual): March 24, 2015

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimate): October 17, 2013

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: April 28, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Soft Tissue Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Anticoagulants; Aspirin; Enoxaparin
• Other Study ID Numbers: IRB-26667; VAR0095 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes