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Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma

2019-10-16 10:39:20 | BioPortfolio

Summary

This is a single arm, single site, feasibility study of Magnetic Resonance Guided Focused Ultrasound (MRgFUS) to promote immunotherapy responses in patients with undifferentiated pleomorphic sarcoma

Description

This study is a single arm, single site, feasibility study to evaluate the safety and efficacy of MRgFUS using the ExAblate 2100 System for the partial ablation of undifferentiated pleomorphic sarcomas. A total of 20 adult participants will be treated with MRgFUS through this study. A matched comparison group of archived samples from patients with UPS who have not received focused ultrasound will be used as a control group to further evaluate the secondary endpoints (stratified and matched for age, sex, and history of neoadjuvant chemotherapy). All patients enrolled will receive timely standard of care surgical resection

Primary Objective:

To evaluate the overall rate and severity of adverse events following pre-operative MRgFUS prior to surgical resection of undifferentiated pleomorphic sarcoma.

Secondary Objectives

1. To measure possible immune response effects related to MRgFUS by serial serological analysis with flow cytometry panels (T-cell, natural killer cell, myeloid panels).

2. To measure possible immune response effects related to MRgFUS by multiplex immunohistochemistry assays of resected tumor specimens (CD3, CD4, CD8, CD19, CD68, FOXP3, PD-1, PD-L1, CD45) as well as RNA sequencing.

3. To compare possible immune response effects in this group of patients receiving pre-operative MRgFUS prior to surgical resection of undifferentiated pleomorphic sarcoma to a comparison group of archived samples from patients who have had resection of UPS but did not have pre-operative focused ultrasound.

Study Design

Conditions

Undifferentiated Pleomorphic Sarcoma

Intervention

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

Location

University of California, San Francisco
San Francisco
California
United States
94143

Status

Not yet recruiting

Source

University of California, San Francisco

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-16T10:39:20-0400

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