Prospective Registry of Histotripsy for Soft Tissue Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Record Review.
- Who it may be relevant to
- Registry conditions: Soft Tissue Neoplasm, Soft Tissue Cancer, Soft Tissue Lesion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Medical Record Review
Data will be collected from the participants medical records.
Primary outcome measures
- Frequency of overall tumor response across all participants [Time frame: up to 3 years]
- Proportion of participants experienced an adverse event [Time frame: Up to 3 years]
- Progression free survival (PFS) [Time frame: up to 3 years]
- Overall Survival (OS) [Time frame: Up to 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT07470008 · 254513