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Procedure

Focused Ultrasound for Sarcoma (HIFU-UPS Trial)

N/A

Recruiting

Led By Matthew Bucknor, MD

Research Sponsored by Matthew Bucknor

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-1

Target tumor >= 2 cm in maximum diameter and <= 20 cm in maximum diameter

Must not have

Subjects with an acute medical condition expected to hinder them from completing the study, unstable cardiovascular status, and severe cerebrovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1-4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new technology is safe and effective for treating a type of cancer.

Who is the study for?

Adults over 18 with a new or suspected diagnosis of undifferentiated pleomorphic sarcoma, who are in good physical condition (ECOG score 0-1) and have tumors accessible to the ExAblate device. Tumors must be visible by MRI, at least 2 cm but no larger than 20 cm, and not too close to critical structures. Patients can't join if they've had recent immunosuppressants, other active cancers, unresolved treatment side effects (except hair loss/fatigue), major surgery/trauma within two weeks, unstable health conditions, contraindications for MRI including metal implants or severe claustrophobia.

What is being tested?

The trial is testing the safety and effectiveness of MRgFUS using the ExAblate System for partially ablating undifferentiated pleomorphic sarcomas. It's a single-site study where all participants receive this focused ultrasound treatment to see how well it works and what side effects occur.

What are the potential side effects?

Potential side effects from MRgFUS may include discomfort at the treatment site, skin burns due to heat exposure from ultrasound energy, bruising or bleeding internally near the tumor area. There might also be risks associated with sedation/anesthesia required during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My tumor is between 2 cm and 20 cm in size.

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My tumor can be removed with surgery, as confirmed by a surgeon or tumor board.

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My tumor can be seen clearly on an MRI scan without contrast.

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My target tumor is in a place where the ExAblate device can reach.

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My target tumor is located more than 1 cm away from any vital body parts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe health conditions that would prevent me from completing the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1-4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1-4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1-4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medical Devices

Secondary study objectives

Immunohistochemistry analyses

Percent change between baseline and post-treatment Cytokine Concentrations

T-Lymphocyte

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Undifferentiated Pleomorphic Sarcoma (UPS)Experimental Treatment1 Intervention

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.

0 / 7Eligibility criteria met