Clinical trial NCT01965002: 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
Overall status: TERMINATED
Phase: NA
Conditions: Soft Tissue Neoplasms
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 5
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Safety - Incidence of Any Device-related Adverse Events
timeFrame: 1 week
Secondary outcomes:
measure: Adverse Event Severity
timeFrame: 6 months
measure: Percent Successful Tumor Ablation
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Raffi Avedian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Pejman Ghanouni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: