Observational Registry of Histotripsy for Soft Tissue Tumors
This study is an observational registry looking at histotripsy, a treatment that uses focused ultrasound waves to break down soft tissue tumors without surgery. The ultrasound waves turn the tumor tissue into liquid. We want to gather information on how well histotripsy works and if it is safe for people with soft tissue tumors, soft tissue cancer, or other soft tissue lesions. You could be included if you are an adult patient receiving histotripsy as part of your regular care at UCSF. We will collect information from your medical records for up to three years to see how your tumor responds, if you experience any side effects, and how long you live without your cancer getting worse.
- Study design
- This is an observational study collecting data from 200 participants' medical records. It is not a randomized trial.
- What's involved
- Your participation involves researchers collecting data from your regular doctor visits via your medical records for three years after your histotripsy procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to three years after their histotripsy procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Prospective Registry of Histotripsy for Soft Tissue Tumors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ryan Lokken, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Frequency of overall tumor response across all participantsup to 3 years
Imaging studies will be conducted to assess for a response across all participants (complete response (CR), Partial response (PR), Stable Disease (SD) and Progressive disease (PD) etc.) using the standardized criteria for tumor response assessment. The standard criteria for European Association for the Study of the Liver (EASL), Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST (mRECIST) will be used to determine response depending on the participant's soft tissue tumor type
- Proportion of participants experienced an adverse eventUp to 3 years
Proportion of participants with adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0). Adverse events will be evaluated using multivariate analysis.
- Progression free survival (PFS)up to 3 years
The analysis of progression-free survival (PFS) will include all participants who have received histotripsy treatment. PFS is defined as the time from the date of histotripsy treatment to the first documented disease progression or death from any cause, whichever occurs first. PFS will be evaluated using time-to-event analysis methods.
- Overall Survival (OS)Up to 3 years
The analysis of OS include participants who have received histotripsy treatment. OS is defined as the of treatment to the time of death. OS will be evaluated using time-to-event analysis methods.