ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for Pleomorphic Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CAPleomorphic SarcomaExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether a new technology is safe and effective for treating a type of cancer.

Eligible Conditions
  • Undifferentiated Pleomorphic Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)
1
CV01-delivered ultrasound
1
Low dose radiation and ALA

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Approximately 1-4 months

Approximately 1-4 months
Cytokine Concentrations
Identification of Immune Cell Populations in Sarcoma Tissue
Immunohistochemistry analyses
Incidence of Any Device-Related Adverse Events
Percent change between baseline and post-treatment Cytokine Concentrations
T-Lymphocyte
Percent change between baseline and post-treatment immune cell populations
Percent change between baseline and post-treatment myeloid cell populations
Percent change between baseline and post-treatment natural killer cell populations
Body tissue
Medical Devices

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)
1
CV01-delivered ultrasound
1
Low dose radiation and ALA

Trial Design

3 Treatment Groups

Group 1: Newly diagnosed local Undifferentiated Pleomorphic Sarcoma (UPS)
1 of 3
Group 2: Metastatic UPS
1 of 3
Undifferentiated Pleomorphic Sarcoma (UPS)
1 of 3

Experimental Treatment

20 Total Participants · 3 Treatment Groups

Primary Treatment: ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) · No Placebo Group · N/A

Group 1: Newly diagnosed local Undifferentiated Pleomorphic Sarcoma (UPS)
Device
Experimental Group · 1 Intervention: ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) · Intervention Types: Device
Group 2: Metastatic UPS
Device
Experimental Group · 1 Intervention: ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) · Intervention Types: Device
Undifferentiated Pleomorphic Sarcoma (UPS)
Device
Experimental Group · 1 Intervention: ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 1-4 months

Who is running the clinical trial?

Focused Ultrasound FoundationOTHER
12 Previous Clinical Trials
333 Total Patients Enrolled
Matthew BucknorLead Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
Matthew Bucknor, MDPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
1 Previous Clinical Trials
56 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your tumor is located in a place where the ExAblate device can reach it, such as soft tissues in the chest, abdomen, pelvis, or arms and legs.
References

Frequently Asked Questions

Could you provide an estimate of how many participants are partaking in this experiment?

"Affirmative. According to the information uploaded on clinicaltrials.gov, this study is recruiting participants and has been since 1/23/2020. The most recent update was made on 9/2/2022, with a goal of enrolling 20 patients from one location." - Anonymous Online Contributor

Unverified Answer

Does this experiment currently require additional volunteers?

"The information that can be found on clinicaltrials.gov displays this trial is in search of participants. It was originally advertised on January 23rd 2020, with the most recent data update occurring September 2nd 2022." - Anonymous Online Contributor

Unverified Answer

What goals is this clinical trial attempting to accomplish?

"This medical trial aspires to assess the occurrence of any device-associated adverse events over a period extending from 1 to 4 months. Secondary objectives include calculating percent change in myeloid cell populations, determining presence of immune cells within sarcoma tissue samples and measuring concentrations of cytokines with serological analyses." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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