Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• To clarify, patient's being treated with institutional standard neoadjuvant chemotherapy may be included in this study if all other inclusion/exclusion criteria are met.

⁃ 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).

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Louise Magat
Louise.Magat@ucsf.edu
(415) 502-1822
Time Frame
Start Date: 2020-01-23
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 20
Treatments
Experimental: Undifferentiated Pleomorphic Sarcoma (UPS)
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.
Sponsors
Collaborators: InSightec-TxSonics, Focused Ultrasound Foundation
Leads: Matthew Bucknor

This content was sourced from clinicaltrials.gov

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