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

• Status: Terminated
• Trial end date: 2015-03-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pejman Ghanouni
• Treatments: Aspirin; Enoxaparin

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