Back to resultsFeasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
Primary Purpose
Soft Tissue Neoplasms
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRgHIFU
Aspirin
Enoxaparin
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Neoplasms
Eligibility Criteria
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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRgHIFU
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01965002
Brief Title
Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Accrual factor
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 24, 2015 (Actual)
Study Completion Date
March 24, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pejman Ghanouni
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRgHIFU
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MRgHIFU
Other Intervention Name(s)
ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Ecotrin
Intervention Description
325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Lovenox
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Safety - Incidence of Any Device-related Adverse Events
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Adverse Event Severity
Description
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
Time Frame
6 months
Title
Percent Successful Tumor Ablation
Description
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.
Time Frame
Up to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffi Avedian, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pejman Ghanouni, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
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