Prospective Registry of Histotripsy for Soft Tissue Tumors

University of California, San Francisco200 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Soft Tissue Neoplasm Soft Tissue Cancer Soft Tissue Lesion

Interventions

Medical Record ReviewOTHER

Data will be collected from the participants medical records.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of California, San Francisco

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 3 years

Central Contacts

Ryan Lokken, MD

CONTACT

877-827-3222 cancertrials@ucsf.edu

Data from ClinicalTrials.gov

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