Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma
NCT04123535 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-08-13
Summary
This study is a single site, single-arm, feasibility study to evaluate the safety and efficacy of MRgFUS using the ExAblate 2100 System for the partial ablation of undifferentiated pleomorphic sarcomas.
Conditions
Interventions
- DEVICE
-
ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)
The ExAblate 2100 MRgFUS system (InSightec, Inc., Dallas, Texas, USA) is a noninvasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.14-16 The ExAblate combines a focused ultrasound surgery (FUS) delivery system and a conventional diagnostic 3T Magnetic Resonance (MR) scanner. The ExAblate systems provide a real-time therapy planning algorithm, thermal dosimetry, and closed-loop therapy control. The ExAblate transducer device is an integrated component of the MR table
Sponsors & Collaborators
-
Focused Ultrasound Foundation
collaborator OTHER -
InSightec-TxSonics
collaborator INDUSTRY -
Matthew Bucknor
lead OTHER
Principal Investigators
-
Matthew Bucknor, MD · University of California, San Francisco
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-23
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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