Prospective Registry of Histotripsy for Soft Tissue Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult participants with diagnosis of and previously recived HIFU
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Medical Record Review
Other interventionData will be collected from the participants medical records.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Participants with Soft Tissue Tumors1 intervention
Trial outcomes
Primary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov