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

NCT01965002 | Terminated Results FDA Device

• 2 other identifiers: IRB-26667VAR0095
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall Safety - Incidence of Any Device-related Adverse Events

  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.

  1 week

Secondary Outcomes (2)

• Adverse Event Severity

  6 months

• Percent Successful Tumor Ablation

  Up to 1 week

Study Arms (1)

MRgHIFU

EXPERIMENTAL

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; Drug: Aspirin; Drug: Enoxaparin

Interventions

MRgHIFU DEVICE

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

Also known as: ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound

MRgHIFU

Aspirin DRUG

325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment

Also known as: Ecotrin

MRgHIFU

Enoxaparin DRUG

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

Also known as: Lovenox

MRgHIFU

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pejman Ghanouni: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Soft Tissue Neoplasms

Interventions

Aspirin; Enoxaparin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Pejman Ghanouni, MD, PhD
• Organization: Stanford Univeristy Medical Center

ghanouni@stanford.edu

650-498-4485

Study Officials

• Raffi Avedian, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Pejman Ghanouni, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 17, 2013
• Study Start: May 1, 2014
• Primary Completion: March 24, 2015
• Study Completion: March 24, 2015
• Last Updated: May 23, 2018
• Results First Posted: May 23, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)