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

Stopped early · Not applicable

Conditions studied: Soft Tissue Neoplasms

In brief

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.

Key facts

Study ID

NCT01965002

Run by

Pejman Ghanouni

People needed

5

Starts

2014-05-01

Expected to finish

2015-03-24

Last updated by the study team

2018-05-23

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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