NCT01965002

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Pejman Ghanouni · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Neoplasms

Interventions

Type	Name	Description
DEVICE	MRgHIFU	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
DRUG	Aspirin	325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
DRUG	Enoxaparin	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

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-03-24
• Completion: 2015-03-24
• First posted: 2013-10-17
• Last updated: 2018-05-23
• Results posted: 2018-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study