Prospective Registry of Histotripsy for Soft Tissue Tumors
Purpose
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.
Conditions
- Soft Tissue Neoplasm
- Soft Tissue Cancer
- Soft Tissue Lesion
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
San Francisco, California 94143
More Details
- Status
- Recruiting
- Sponsor
- University of California, San Francisco
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.