Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma

NCT04123535 | Recruiting DMC FDA Device

• 2 other identifiers: 19653NCI-2019-06737
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Undifferentiated Pleomorphic Sarcoma

Keywords

Focused Ultrasound; Sarcoma

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with reported Device-Related Adverse Events

  Proportion of participants with device-related adverse events will be determined by evaluating the incidence and severity of any device-related complications from the treatment day visit through the time of surgery or last post-treatment point. Patients will be followed for any reported adverse events following MRgFUS, per the Common Terminology Criteria for Adverse Events version 5.0

  Approximately 1-4 months

Secondary Outcomes (6)

• Percent change between baseline and post-treatment T-cell populations

  Approximately 1-4 months

• Percent change between baseline and post-treatment natural killer cell populations

  Approximately 1-4 months

• Percent change between baseline and post-treatment myeloid cell populations

  Approximately 1-4 months

• Percent change between baseline and post-treatment Cytokine Concentrations

  Approximately 1-4 months

• Presence of Immune Cell Populations in Sarcoma Tissue

  Approximately 1-4 months

Study Arms (1)

Undifferentiated Pleomorphic Sarcoma (UPS)

EXPERIMENTAL

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.

Device: ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)

Interventions

ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) DEVICE

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

Also known as: ExAblate 2000/2100, MRgFUS

Undifferentiated Pleomorphic Sarcoma (UPS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women \>= 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-1.
• Subjects must have either 1) a biopsy-proven new diagnosis of undifferentiated pleomorphic sarcoma (UPS) (within the last 6 months) or 2) a lesion highly suspicious for metastatic UPS based on CT or MRI imaging (within the last 6 months).
• Target tumor \>= 2 cm in maximum diameter and \<= 20 cm in maximum diameter.
• Target tumor accessible to the ExAblate device in the soft tissues of the chest, abdomen, pelvis, or upper or lower extremities.
• Target tumor must be \> 1 cm from any critical structure. Critical structures are defined as skin, major nerve/vascular bundles, nerve roots, any solid organ, and any portion of the bowel.
• Target tumor must be clearly visible by non-contrast magnetic resonance imaging (MRI)
• For patients with newly diagnosed, not previously treated UPS, tumor must be deemed to be surgically resectable by tumor board documentation or surgeon's note.

You may not qualify if:

• Note: There has never been a prospective study comparing patients receiving chemotherapy to those not receiving chemotherapy in the neoadjuvant setting for soft tissue sarcoma. Our local institutional standard is to treat patients with neoadjuvant chemotherapy prior to surgical resection when tumors are \> 5 cm in maximal dimension and within deep muscular compartments. Our institutional standard is to treat patients with doxorubicin plus ifosfamide for younger patients (typically \<50 years old) and gemcitabine plus taxotere for older patients (typically \>= 50 years old).
• Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) treatment date.
• History of interstitial lung disease or other active malignancy (may confound immune response results).
• History of previous malignancies (except non-melanoma skin cancers) (may confound immune response results).
• All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline.
• Subjects must have recovered from the effects of major surgery or significant trauma at least 14 days before the study procedure.
• Subjects with an acute medical condition expected to hinder them from completing the study, unstable cardiovascular status, and severe cerebrovascular disease.
• Treatment with any investigational agent within 28 days of the treatment procedure.
• Any absolute contraindications for study magnetic resonance imaging (MRI) per standard University of California, San Francisco (UCSF) departmental MRI safety guidance (https://radiology.ucsf.edu/patient-care/patient-safety/mri) and additionally:
• Metal in other parts of body that will cause safety issues
• Claustrophobia
• Weight \> 400 pounds (lb) or 181.4 kilograms (kg).
• Pregnancy
• Known intolerance or allergy to magnetic resonance (MR) contrast agent (gadolinium chelates)
• Unable to safely receive anesthesia/sedation for the treatment, or known intolerance or allergy to medications used for sedation/anesthesia.

Sponsors & Collaborators

• Matthew Bucknor: lead
• Focused Ultrasound Foundation: collaborator
• InSightec-TxSonics: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Histiocytoma, Malignant Fibrous; Sarcoma

Condition Hierarchy (Ancestors)

Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Matthew Bucknor, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Magat

CONTACT

(415) 502-1822; Louise.Magat@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor in Residence

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: January 23, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)