Soft Tissue Neoplasm, Soft Tissue Cancer, Soft Tissue Lesion
Conditions
Keywords
Histotripsy, Ablation
Brief summary
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.
Detailed description
PRIMARY OBJECTIVES: 1. Tumor response on imaging will be assessed using standardized criteria for tumor types such as European Association for the Study of the Liver (EASL), Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST (mRECIST). 2. Progression free survival and overall survival. 3. Risk factors for adverse events identified by NCI Common Terminology Criteria for Adverse Events (CTCAE). OUTLINE: Researchers will collect data from participants' regular doctor visits via medical records for three years after the Histotripsy procedure has taken place.
Interventions
Data will be collected from the participants medical records.
Sponsors
University of California, San Francisco
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients who are treated with histotripsy per standard clinical care at University of California San Francisco (UCSF) are eligible for inclusion in the registry.
Exclusion criteria
* Children/minors, and adults who lack decision-making capacity, will be excluded from the registry. Patients who do not consent for inclusion in the registry will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of overall tumor response across all participants | up 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 event | Up 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. |
Countries
United States
Contacts
CONTACTRyan Lokken, MD
PRINCIPAL_INVESTIGATORRyan Lokken, MD
University of California, San Francisco
Outcome results
None listed