NCT07470008

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
62mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Aug 2031

Study Start

First participant enrolled

January 29, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2031

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

March 10, 2026

Last Update Submit

March 13, 2026

Conditions

Soft Tissue NeoplasmSoft Tissue CancerSoft Tissue Lesion

Keywords

HistotripsyAblation

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

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.

Other: Medical Record Review

Interventions

Medical Record ReviewOTHER

Data will be collected from the participants medical records.

Also known as: Chart Review
Participants with Soft Tissue Tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants with diagnosis of and previously recived HIFU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Soft Tissue NeoplasmsSarcoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

  • Ryan Lokken, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Lokken, MD

CONTACT

877-827-3222cancertrials@ucsf.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

January 29, 2026

Primary Completion (Estimated)

August 8, 2030

Study Completion (Estimated)

August 8, 2031

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)