Focused Ultrasound for Sarcoma
(HIFU-UPS Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking corticosteroids or other immunosuppressive medications at least 14 days before the treatment. If you are on these medications, you will need to stop them to participate.
What data supports the effectiveness of the treatment ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for sarcoma?
Research shows that MRgFUS, using systems like ExAblate 2100, has been effective in treating various tumors, including breast and bone tumors, by noninvasively targeting and destroying tumor tissue. It has also been used to relieve pain in patients with bone metastases, suggesting its potential effectiveness in managing sarcoma.12345
Is focused ultrasound generally safe for humans?
Focused ultrasound, using systems like ExAblate, has been studied for various conditions such as breast cancer, bone tumors, and pain from bone metastases. These studies suggest that it is generally safe, as it is a noninvasive technique that has been used effectively for tumor treatment and pain relief without major safety concerns.12356
How is the treatment ExAblate 2000/2100 MRgFUS different from other treatments for sarcoma?
Research Team
Matthew Bucknor, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
Adults over 18 with a new or suspected diagnosis of undifferentiated pleomorphic sarcoma, who are in good physical condition (ECOG score 0-1) and have tumors accessible to the ExAblate device. Tumors must be visible by MRI, at least 2 cm but no larger than 20 cm, and not too close to critical structures. Patients can't join if they've had recent immunosuppressants, other active cancers, unresolved treatment side effects (except hair loss/fatigue), major surgery/trauma within two weeks, unstable health conditions, contraindications for MRI including metal implants or severe claustrophobia.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment Biopsy
Pre-procedure biopsy of the metastatic tumor target is conducted
Treatment
Participants receive MRgFUS treatment 1-4 weeks prior to surgical resection
Surgical Resection
Standard of care surgical resection is performed as clinically indicated
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)
ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) is already approved in United States for the following indications:
- Uterine fibroids (leiomyomata)
- Palliation of pain associated with tumors metastatic to bone
- Medication refractory essential tremor
- Tremor-dominant Parkinson disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Matthew Bucknor
Lead Sponsor
InSightec-TxSonics
Industry Sponsor
Focused Ultrasound Foundation
Collaborator