Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma (HIFU-UPS)

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Matthew Bucknor
Updated on 8 August 2022

Summary

This study is a single site, two-arm, feasibility study to evaluate the safety and efficacy of MRgFUS using the ExAblate 2100 System for the partial ablation of undifferentiated pleomorphic sarcomas.

Description

A total of 20 adult participants will be treated with MRgFUS through this study. A matched comparison group (Group 1) 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, as clinically indicated. For patients enrolled with metastatic disease, Group 2, pre- and post-MRgFUS biopsy samples will be obtained

PRIMARY OBJECTIVE:

I. To evaluate the overall rate and severity of adverse events following MRgFUS of newly diagnosed or metastatic undifferentiated pleomorphic sarcoma.

SECONDARY OBJECTIVES:

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

II. 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.

III. To compare possible immune response effects in patients receiving MRgFUS prior to either surgical resection or follow-up biopsy of undifferentiated pleomorphic sarcoma to either 1) a comparison group of archived samples from patients who have had resection of UPS but did not have pre-operative focused ultrasound (for patients with newly diagnosed local disease or 2) individual pre-MRgFUS biopsy analyses.

Details
Condition Undifferentiated Pleomorphic Sarcoma
Treatment ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)
Clinical Study IdentifierNCT04123535
SponsorMatthew Bucknor
Last Modified on8 August 2022

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