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

Not Recruiting

Trial ID: NCT01965002

Purpose

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.

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

Stanford Investigator(s)

Raffi S. Avedian, MD
Raffi S. Avedian, MD

Associate Professor of Orthopaedic Surgery

Pejman Ghanouni, MD, PhD
Pejman Ghanouni, MD, PhD

Associate Professor of Radiology (General Radiology) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology

Eligibility

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

Intervention(s):

device: MRgHIFU

drug: Aspirin

drug: Enoxaparin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061

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