20 Participants Needed

Focused Ultrasound for Sarcoma

(HIFU-UPS Trial)

MA
LM
Overseen ByLouise Magat
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

ExAblate 2000/2100 MRgFUS is unique because it is a non-invasive treatment that uses focused ultrasound waves guided by MRI to target and destroy tumors without surgery, which is different from traditional treatments like surgery or chemotherapy.12357

Research Team

MB

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

I am fully active or can carry out light work.
I was recently diagnosed with undifferentiated pleomorphic sarcoma or have a lesion suspected to be this cancer.
My tumor is between 2 cm and 20 cm in size.
See 5 more

Exclusion Criteria

I do not have any severe health conditions that would prevent me from completing the study.
I am newly diagnosed and will have or had initial radiation therapy.
I haven't taken steroids or immunosuppressants in the last 14 days.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Biopsy

Pre-procedure biopsy of the metastatic tumor target is conducted

2 weeks
1 visit (in-person)

Treatment

Participants receive MRgFUS treatment 1-4 weeks prior to surgical resection

1-4 weeks
1 visit (in-person)

Surgical Resection

Standard of care surgical resection is performed as clinically indicated

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-4 months

Treatment Details

Interventions

  • ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)
Trial Overview The trial is testing the safety and effectiveness of MRgFUS using the ExAblate System for partially ablating undifferentiated pleomorphic sarcomas. It's a single-site study where all participants receive this focused ultrasound treatment to see how well it works and what side effects occur.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Undifferentiated Pleomorphic Sarcoma (UPS)Experimental Treatment1 Intervention
All enrolled participants will be scheduled to receive pre-operative MRgFUS with the ExAblate 2000/2100 MRgFUS system 1-4 weeks prior to surgical resection of their tumor or approximately 2 weeks after a pre-procedure biopsy of the metastatic tumor target depending on diagnosis at enrollment. For patients enrolled with metastatic disease, pre and post-MRgFUS biopsy samples will be obtained.

ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) is already approved in United States for the following indications:

🇺🇸
Approved in United States as ExAblate MRgFUS for:
  • 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

Trials
2
Recruited
80+

InSightec-TxSonics

Industry Sponsor

Trials
2
Recruited
70+

Focused Ultrasound Foundation

Collaborator

Trials
18
Recruited
460+

Findings from Research

In a study involving 24 patients, MRgFUS demonstrated significant efficacy in treating benign bone tumors, achieving complete ablation with minimal adverse effects, and effectively reducing pain in patients with metastatic bone disease.
The treatment resulted in 100% necrosis of ablated primary malignant tumors, indicating its potential as a safe and noninvasive option for managing both primary and metastatic bone tumors.
Magnetic resonance guided focused ultrasound for treatment of bone tumors.Singh, VA., Shah, SU., Yasin, NF., et al.[2018]
The first clinical experience with MRgFUS using the ExAblate 2100 system for non-invasive breast cancer showed promising results, with no severe adverse events reported in two patients.
Pathological examinations indicated that the treatment effectively induced tumor necrosis, suggesting that MRgFUS is a safe and feasible option for non-invasive breast cancer treatment.
Innovative use of magnetic resonance imaging-guided focused ultrasound surgery for non-invasive breast cancer: a report of two cases.Matsutani, A., Ide, Y., Miura, S., et al.[2020]
In a study involving 30 women with breast cancer, MRgFUS treatment resulted in an impressive average of 96.9% tumor necrosis, indicating its high effectiveness in ablating breast carcinomas.
The procedure was well tolerated with minimal adverse effects, especially when performed under local anesthesia, suggesting it could be a safe noninvasive alternative to traditional surgical methods like lumpectomy.
Magnetic resonance-guided focused ultrasound surgery of breast cancer: reliability and effectiveness.Furusawa, H., Namba, K., Thomsen, S., et al.[2022]

References

Magnetic resonance guided focused ultrasound for treatment of bone tumors. [2018]
Innovative use of magnetic resonance imaging-guided focused ultrasound surgery for non-invasive breast cancer: a report of two cases. [2020]
Magnetic resonance-guided focused ultrasound surgery of breast cancer: reliability and effectiveness. [2022]
Critical role of HIFU in musculoskeletal interventions. [2021]
MR-guided focused ultrasound surgery (MRgFUS) for the palliation of pain in patients with bone metastases--preliminary clinical experience. [2022]
Initial experience with magnetic resonance-guided focused ultrasound stereotactic surgery for central brain lesions in young adults. [2022]
Pain palliation in patients with bone metastases using magnetic resonance-guided focused ultrasound with conformal bone system: a preliminary report. [2018]