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

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ClinicalTrials.gov Identifier: NCT01965002
Recruitment Status : Terminated (Accrual factor)
First Posted : October 17, 2013
Results First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Pejman Ghanouni, Stanford University

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.

Condition or disease Intervention/treatment Phase
Soft Tissue Neoplasms Device: MRgHIFU Drug: Aspirin Drug: Enoxaparin Not Applicable

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  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : March 24, 2015
Actual Study Completion Date : March 24, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: 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 Name: 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 Name: Lovenox




Primary Outcome Measures :
  1. Overall Safety - Incidence of Any Device-related Adverse Events [ Time Frame: 1 week ]
    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 :
  1. Adverse Event Severity [ Time Frame: 6 months ]

    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:

    1. mild
    2. moderate
    3. severe
    4. life-threatening
    5. fatal

  2. Percent Successful Tumor Ablation [ Time Frame: Up to 1 week ]
    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.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965002


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Pejman Ghanouni
Investigators
Principal Investigator: Raffi Avedian, MD Stanford University
Principal Investigator: Pejman Ghanouni, MD, PhD Stanford University

Responsible Party: Pejman Ghanouni, Assistant Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01965002     History of Changes
Other Study ID Numbers: IRB-26667
VAR0095 ( Other Identifier: OnCore )
First Posted: October 17, 2013    Key Record Dates
Results First Posted: May 23, 2018
Last Update Posted: May 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Soft Tissue Neoplasms
Neoplasms by Site
Neoplasms