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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1-4 months
Awards & highlights
HIFU-UPS Trial 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.Check my eligibility
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.See study design
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.
HIFU-UPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
HIFU-UPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 1-4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1-4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Medical Devices
Secondary outcome measures
Immunohistochemistry analyses
Percent change between baseline and post-treatment Cytokine Concentrations
T-Lymphocyte
+3 moreHIFU-UPS 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.
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Who is running the clinical trial?
InSightec-TxSonicsIndustry Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Matthew BucknorLead Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
Focused Ultrasound FoundationOTHER
15 Previous Clinical Trials
294 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe health conditions that would prevent me from completing the study.I am fully active or can carry out light work.I was recently diagnosed with undifferentiated pleomorphic sarcoma or have a lesion suspected to be this cancer.I am newly diagnosed and will have or had initial radiation therapy.My tumor is between 2 cm and 20 cm in size.I haven't taken steroids or immunosuppressants in the last 14 days.I have recovered from major surgery or serious injury for at least 2 weeks.My tumor can be removed with surgery, as confirmed by a surgeon or tumor board.My tumor can be seen clearly on an MRI scan without contrast.My target tumor is in a place where the ExAblate device can reach.I have had cancer before, but not skin cancer.All my side effects from cancer treatment, except hair loss and tiredness, are mild or gone.I do not have a history of lung disease or any other active cancer.I am 18 years old or older.My target tumor is located more than 1 cm away from any vital body parts.I am currently on standard chemotherapy as part of my pre-surgery treatment plan.You have not taken any experimental drugs in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Undifferentiated Pleomorphic Sarcoma (UPS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide an estimate of how many participants are partaking in this experiment?
"Affirmative. According to the information uploaded on clinicaltrials.gov, this study is recruiting participants and has been since 1/23/2020. The most recent update was made on 9/2/2022, with a goal of enrolling 20 patients from one location."
Answered by AI
Does this experiment currently require additional volunteers?
"The information that can be found on clinicaltrials.gov displays this trial is in search of participants. It was originally advertised on January 23rd 2020, with the most recent data update occurring September 2nd 2022."
Answered by AI
What goals is this clinical trial attempting to accomplish?
"This medical trial aspires to assess the occurrence of any device-associated adverse events over a period extending from 1 to 4 months. Secondary objectives include calculating percent change in myeloid cell populations, determining presence of immune cells within sarcoma tissue samples and measuring concentrations of cytokines with serological analyses."
Answered by AI
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