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Histotripsy is a treatment that uses focused ultrasound waves to break down tissue without surgery. The ultrasound waves meet at a specific spot and turn the tissue into liquid. This study is a prospective observational registry of participants receiving histotripsy. The goal of this study is to gather information about the use of histotripsy to confirm it is safe and effective medical procedure.
PRIMARY OBJECTIVES:
OUTLINE:
Researchers will collect data from participants' regular doctor visits via medical records for three years after the Histotripsy procedure has taken place.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Soft Tissue Tumors | Participant data will be collected from participants' medical records. Cancer history, laboratory analysis, histotripsy procedure details, adverse events, and oncological outcomes of the procedure along with demographic data will be collected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Record Review | Other | Data will be collected from the participants medical records. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of overall tumor response across all participants | 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 | up to 3 years |
| Proportion of participants experienced an adverse event | 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. | Up to 3 years |
| Progression free survival (PFS) | 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. | up to 3 years |
| Overall Survival (OS) | 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. | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with diagnosis of and previously recived HIFU
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Lokken, MD | Contact | 877-827-3222 | cancertrials@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ryan Lokken, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D012983 | Soft Tissue Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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