This study is accepting new patients by invitation only

Prospective Registry of Histotripsy for Soft Tissue Tumors

a study on Soft Tissue Neoplasm Soft Tissue Cancer Soft Tissue Lesion Sarcoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Ryan Lokken, MD

Description

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.

Details

CURRENTLY ONY ENROLLING PATIENTS AT UCSF REFERRED BY PHYSICIAN.

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 consenting participants' regular doctor visits via medical records for three years after the Histotripsy procedure has taken place.

Keywords

Soft Tissue Neoplasm, Soft Tissue Cancer, Soft Tissue Lesion, Histotripsy, Ablation, Soft Tissue Neoplasms, Sarcoma, Medical Record Review

Eligibility

For people ages 18 years and up

CURRENTLY ONY ENROLLING PATIENTS AT UCSF REFERRED BY PHYSICIAN.

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.

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07470008
Study Type
Observational [Patient Registry]
Participants
Expecting 200 study participants
Last Updated