Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma (HIFU-UPS)
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|ClinicalTrials.gov Identifier: NCT04123535|
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Undifferentiated Pleomorphic Sarcoma||Device: ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)||Not Applicable|
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
To evaluate the overall rate and severity of adverse events following pre-operative MRgFUS prior to surgical resection of undifferentiated pleomorphic sarcoma.
- To measure possible immune response effects related to MRgFUS by serial serological analysis with flow cytometry panels (T-cell, natural killer cell, myeloid panels).
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study is a single arm, single site, feasibility study with a matched comparison group of archived samples for secondary endpoints|
|Masking:||None (Open Label)|
|Official Title:||Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma|
|Actual Study Start Date :||January 23, 2020|
|Estimated Primary Completion Date :||July 23, 2022|
|Estimated Study Completion Date :||July 23, 2022|
Experimental: Magnetic Resonance-guided Focused Ultrasound (MRgFUS)
Pre-operative MRgFUS with the ExAblate 2000/2100 MRgFUS system 1-4 weeks prior to surgical resection of their tumor
Device: ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)
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
- Incidence of Any Device-Related Adverse Events [ Time Frame: Approximately 1-4 months ]Patients will be followed for any reported adverse events following Magnetic Resonance-guided Focused Ultrasound (MRgFUS), using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and evaluated on incidence and severity to create a safety profile. Device-related Adverse Events (AEs) will be will be summarized as percentages, with computed confidence intervals.
- Percent change between baseline and post-treatment immune cell populations [ Time Frame: Approximately 1-4 months ]Blood samples obtained at 1 week prior to MRgFUS and at 1 week post MRgFUS will be sent to the University of California, San Francisco (UCSF) Cancer Immunotherapy Lab. Flow cytometry panels will be performed to evaluate T-cell, natural killer cell, and myeloid cell populations. Cytokine concentrations will also be measured. Percent change between baseline and post-treatment samples will be calculated and displayed as a table
- Cytokine Concentrations [ Time Frame: Approximately 1-4 months ]Serological analyses: blood samples obtained at 1 week prior to MRgFUS and at 1 week post MRgFUS. Cytokine concentrations will also be measured. Percent change between baseline and post-treatment samples will be calculated
- Identification of Immune Cell Populations in Sarcoma Tissue [ Time Frame: Approximately 1-4 months ]Immune populations in tumor specimens, including populations of CD3, CD4, CD8, CD19, CD68, FOXP3, PD-1, PD-L1, and CD45 positive cells will be determined. RNA sequencing will also be performed. Identification if displayed as a table
- Immunohistochemistry analyses [ Time Frame: Approximately 1-4 months ]Immunohistochemistry analyses will be compared to an archived matched group of patients (matched for age, sex, and history of neoadjuvant chemotherapy) who had resection of UPS without pre-operative MRgFUS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123535
|Contact: Maya Aslamemail@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Maya Aslam, BA 877-827-3222 firstname.lastname@example.org|
|Principal Investigator: Matthew Bucknor, MD|
|Principal Investigator:||Matthew Bucknor, MD||University of California, San Francisco|