Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04123535

Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma

Led by Matthew Bucknor · Updated on 2025-08-13

20

Participants Needed

1

Research Sites

335 weeks

Total Duration

On this page

Sponsors

M

Matthew Bucknor

Lead Sponsor

F

Focused Ultrasound Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women 18 years or older
  • ECOG performance status score of 0 or 1
  • Biopsy-proven new diagnosis of undifferentiated pleomorphic sarcoma within the last 6 months or lesion suspected as metastatic UPS on recent CT or MRI
  • Target tumor size between 2 cm and 20 cm in maximum diameter
  • Tumor located in soft tissues of chest, abdomen, pelvis, or extremities accessible by the ExAblate device
  • Tumor must be more than 1 cm away from critical structures such as skin, major nerves, vessels, nerve roots, solid organs, and bowel
  • Tumor clearly visible on non-contrast MRI
  • For newly diagnosed UPS, tumor must be surgically resectable as documented by tumor board or surgeon
  • Patients receiving standard neoadjuvant chemotherapy may be included if all other criteria are met
Not Eligible

You will not qualify if you...

  • Need for systemic corticosteroids or immunosuppressive drugs within 14 days before MRgFUS treatment
  • History of interstitial lung disease or other active cancers that may affect immune results
  • Previous malignancies except non-melanoma skin cancers
  • Unresolved toxicities from prior cancer therapy except hair loss and fatigue
  • Recovery from major surgery or trauma less than 14 days before study procedure
  • Acute medical conditions, unstable heart status, or severe cerebrovascular disease
  • Treatment with any investigational drug within 28 days before treatment
  • Contraindications to MRI including metal implants causing safety issues, claustrophobia, weight over 400 pounds (181.4 kg), pregnancy, or allergy to MRI contrast
  • Unable to safely receive anesthesia or sedation or allergy to sedation medications
  • Inability to communicate verbally with study staff
  • For newly diagnosed patients only: prior or planned neoadjuvant radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

L

Louise Magat

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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