Undifferentiated Pleomorphic SarcomaHIFU-UPSNCT04123535
Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma
A study testing ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) in people with Undifferentiated Pleomorphic Sarcoma, run by Matthew Bucknor at 1 site in United States.
Trial summary
This study is a single site, single-arm, feasibility study to evaluate the safety and efficacy of MRgFUS using the ExAblate 2100 System for the partial ablation of undifferentiated pleomorphic sarcomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undifferentiated Pleomorphic Sarcoma
- What is being tested?
- ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women >= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-1.
- Subjects must have either 1) a biopsy-proven new diagnosis of undifferentiated pleomorphic sarcoma (UPS) (within the last 6 months) or 2) a lesion highly suspicious for metastatic UPS based on CT or MRI imaging (within the last 6 months).
- Target tumor >= 2 cm in maximum diameter and <= 20 cm in maximum diameter.
- Target tumor accessible to the ExAblate device in the soft tissues of the chest, abdomen, pelvis, or upper or lower extremities.
- Target tumor must be > 1 cm from any critical structure. Critical structures are defined as skin, major nerve/vascular bundles, nerve roots, any solid organ, and any portion of the bowel.
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- Target tumor must be clearly visible by non-contrast magnetic resonance imaging (MRI)
- For patients with newly diagnosed, not previously treated UPS, tumor must be deemed to be surgically resectable by tumor board documentation or surgeon's note.
- To clarify, patient's being treated with institutional standard neoadjuvant chemotherapy may be included in this study if all other inclusion/exclusion criteria are met.
- Note: There has never been a prospective study comparing patients receiving chemotherapy to those not receiving chemotherapy in the neoadjuvant setting for soft tissue sarcoma. Our local institutional standard is to treat patients with neoadjuvant chemotherapy prior to surgical resection when tumors are > 5 cm in maximal dimension and within deep muscular compartments. Our institutional standard is to treat patients with doxorubicin plus ifosfamide for younger patients (typically <50 years old) and gemcitabine plus taxotere for older patients (typically >= 50 years old).
Who cannot join
- Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) treatment date.
- History of interstitial lung disease or other active malignancy (may confound immune response results).
- History of previous malignancies (except non-melanoma skin cancers) (may confound immune response results).
- All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline.
- Subjects must have recovered from the effects of major surgery or significant trauma at least 14 days before the study procedure.
- Subjects with an acute medical condition expected to hinder them from completing the study, unstable cardiovascular status, and severe cerebrovascular disease.
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- Treatment with any investigational agent within 28 days of the treatment procedure.
- Any absolute contraindications for study magnetic resonance imaging (MRI) per standard University of California, San Francisco (UCSF) departmental MRI safety guidance (https://radiology.ucsf.edu/patient-care/patient-safety/mri) and additionally:
- Metal in other parts of body that will cause safety issues
- Claustrophobia
- Weight > 400 pounds (lb) or 181.4 kilograms (kg).
- Pregnancy
- Known intolerance or allergy to magnetic resonance (MR) contrast agent (gadolinium chelates)
- Unable to safely receive anesthesia/sedation for the treatment, or known intolerance or allergy to medications used for sedation/anesthesia.
- Unable to verbally communicate with the investigator and staff.
- For Group 1 Patients (newly diagnosed disease) only: Have received neoadjuvant radiotherapy or planning to receive neoadjuvant radiotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
This study is a single site, single-arm, feasibility study to evaluate the safety and efficacy of MRgFUS using the ExAblate 2100 System for the partial ablation of undifferentiated pleomorphic sarcomas.
Read the detailed description
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, as clinically indicated. For patients enrolled with metastatic disease pre- and post-MRgFUS biopsy samples will be obtained
PRIMARY OBJECTIVE:
- To evaluate the overall rate and severity of adverse events following MRgFUS of newly diagnosed or metastatic undifferentiated pleomorphic sarcoma.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Undifferentiated Pleomorphic Sarcoma
- Being tested
- ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)
- Keywords
- Focused Ultrasound, Sarcoma
- Medical subject headings
- Histiocytoma, Malignant Fibrous, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)Device
Also called ExAblate 2000/2100, 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
| Study group | Role | What they receive |
|---|---|---|
| Undifferentiated Pleomorphic Sarcoma (UPS) | Experimental | 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. Receives: Device: ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with reported Device-Related Adverse Events
Proportion of participants with device-related adverse events will be determined by evaluating the incidence and severity of any device-related complications from the treatment day visit through the time of surgery or last post-treatment point. Patients will be followed for any reported adverse events following MRgFUS, per the Common Terminology Criteria for Adverse Events version 5.0
Measured: Approximately 1-4 months
Secondary outcomes (6)
Percent change between baseline and post-treatment T-cell populations
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 populations. Percent change between baseline and post-treatment samples will be calculated and displayed as a table
Measured: Approximately 1-4 months
Percent change between baseline and post-treatment natural killer cell populations
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 natural killer cell populations. Percent change between baseline and post-treatment samples will be calculated and displayed as a table
Measured: Approximately 1-4 months
Percent change between baseline and post-treatment myeloid cell populations
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 myeloid cell populations. Percent change between baseline and post-treatment samples will be calculated and displayed as a table
Measured: Approximately 1-4 months
Percent change between baseline and post-treatment Cytokine Concentrations
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
Measured: Approximately 1-4 months
Presence of Immune Cell Populations in Sarcoma Tissue
The detectable presence of various 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.
Measured: Approximately 1-4 months
Immunohistochemistry analyses
Immunohistochemistry analyses in patients with newly diagnosed local UPS 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. Nanostring digital spatial profiling may also be used for tissue analysis
Measured: Approximately 1-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start23 Jan 2020
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undifferentiated Pleomorphic SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Bucknor
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation, InSightec-TxSonics
- Responsible party
- Sponsor-investigator, Matthew Bucknor, University of California, San Francisco
- Investigators
- Matthew Bucknor, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123535
- Sponsor's protocol ID
- 19653
- Other IDs
- NCI-2019-06737
- Acronym
- HIFU-UPS
- Status last verified
- May 2026
- First submitted
- 9 Oct 2019
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma
- ClinicalTrials.gov ID
- NCT04123535
- Acronym / sponsor ID
- HIFU-UPS / 19653
- Conditions
- Undifferentiated Pleomorphic Sarcoma
- Keywords
- Focused Ultrasound, Sarcoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Matthew BucknorUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation, InSightec-TxSonics
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single site, single-arm, feasibility study to evaluate the safety and efficacy of MRgFUS using the ExAblate 2100 System for the partial ablation of undifferentiated pleomorphic sarcomas.
Detailed description
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, as clinically indicated. For patients enrolled with metastatic disease pre- and post-MRgFUS biopsy samples will be obtained
PRIMARY OBJECTIVE:
- To evaluate the overall rate and severity of adverse events following MRgFUS of newly diagnosed or metastatic undifferentiated pleomorphic sarcoma.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undifferentiated Pleomorphic Sarcoma (UPS) | Experimental | Device: ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women >= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-1.
- Subjects must have either 1) a biopsy-proven new diagnosis of undifferentiated pleomorphic sarcoma (UPS) (within the last 6 months) or 2) a lesion highly suspicious for metastatic UPS based on CT or MRI imaging (within the last 6 months).
- Target tumor >= 2 cm in maximum diameter and <= 20 cm in maximum diameter.
- Target tumor accessible to the ExAblate device in the soft tissues of the chest, abdomen, pelvis, or upper or lower extremities.
Key exclusion criteria (16 listed)
- Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) treatment date.
- History of interstitial lung disease or other active malignancy (may confound immune response results).
- History of previous malignancies (except non-melanoma skin cancers) (may confound immune response results).
- All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline.
- Subjects must have recovered from the effects of major surgery or significant trauma at least 14 days before the study procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)Also: ExAblate 2000/2100, MRgFUSThe 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 | Device | Undifferentiated Pleomorphic Sarcoma (UPS) |
Primary outcome
Proportion of participants with reported Device-Related Adverse Events
Time frame: Approximately 1-4 months
Proportion of participants with device-related adverse events will be determined by evaluating the incidence and severity of any device-related complications from the treatment day visit through the time of surgery or last post-treatment point. Patients will be followed for any reported adverse events following MRgFUS, per the Common Terminology Criteria for Adverse Events version 5.0
6 secondary outcomes
Percent change between baseline and post-treatment T-cell populations
Time frame: Approximately 1-4 months
Percent change between baseline and post-treatment natural killer cell populations
Time frame: Approximately 1-4 months
Percent change between baseline and post-treatment myeloid cell populations
Time frame: Approximately 1-4 months
Percent change between baseline and post-treatment Cytokine Concentrations
Time frame: Approximately 1-4 months
Presence of Immune Cell Populations in Sarcoma Tissue
Time frame: Approximately 1-4 months
Immunohistochemistry analyses
Time frame: Approximately 1-4 months
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Bucknor, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) in people with Undifferentiated Pleomorphic Sarcoma, run by Matthew Bucknor at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with reported Device-Related Adverse Events (time frame: Approximately 1-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.