Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01965002|
Recruitment Status : Terminated (Accrual factor)
First Posted : October 17, 2013
Results First Posted : May 23, 2018
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Neoplasms||Device: MRgHIFU Drug: Aspirin Drug: Enoxaparin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2014|
|Actual Primary Completion Date :||March 24, 2015|
|Actual Study Completion Date :||March 24, 2015|
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.
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
Other Name: ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound
325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
Other Name: Ecotrin
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
Other Name: Lovenox
- Overall Safety - Incidence of Any Device-related Adverse Events [ Time Frame: 1 week ]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.
- Adverse Event Severity [ Time Frame: 6 months ]
Safety is further assessed by an evaluation of severity for the treatment-related adverse events, reported as the number of adverse events for each of the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades.
- Percent Successful Tumor Ablation [ Time Frame: Up to 1 week ]In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice. The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed. Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965002
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Raffi Avedian, MD||Stanford University|
|Principal Investigator:||Pejman Ghanouni, MD, PhD||Stanford University|