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Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry


2019-12-06


2023-11-30


2023-11-30


21

Study Overview

Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry

This pancreatic cancer registry aims to collect information on people around the world who select focused ultrasound (FUS) as part of their treatment for pancreatic cancer to learn about the performance of the focused ultrasound technology and health outcomes; the impact of focused ultrasound on your overall health; and provide an understanding of the current care for pancreatic cancer.

The purpose of the registry is to collect data on the performance of the focused ultrasound (FUS) technology and health outcomes. A wide variety of approaches exist for using FUS on pancreatic cancer patients, and the primary goal is to capture this broad spectrum of approaches and their impact on patients overall health. This information will help provide a better understanding of current care, and may possibly direct further, more specific investigations that will follow this registry. After obtaining informed consent a baseline history, physical examination, laboratory studies, and imaging studies needed per standard of care will be performed. Patients' treatment is determined by their caregivers only, and thus the registry will evaluate patient management in "real-world" conditions. Enrollment Goal: 100 Primary Outcomes: Pain related to pancreatic cancer, Objective response, Progression-free and overall survival, Performance Status, Clinical Benefit Response (CBR), Health-related quality of life

  • Pancreatic Cancer
    • FUSREG001

    Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

    Study Registration Dates Results Reporting Dates Study Record Updates

    2018-08-31  

    N/A  

    2024-03-14  

    2018-10-26  

    N/A  

    2024-03-18  

    2018-10-30  

    N/A  

    2024-03  

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    Design Details

    Primary Purpose:
    N/A


    Allocation:
    N/A


    Interventional Model:
    N/A


    Masking:
    N/A


    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    : Pancreatic Cancer Participants

    No intervention will be administered. Assessments are performed as standard of care.

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    SurvivalTime until the occurence of death1 year
    Secondary Outcome MeasuresMeasure DescriptionTime Frame

    Contacts and Locations

    This section provides the contact details for those conducting the study, and information on where this study is being conducted.

    Participation Criteria

    Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:
    18 Years

    Accepts Healthy Volunteers:

      Inclusion Criteria:

    • Provision of signed and dated informed consent form
    • Stated willingness to comply with all registry procedures and availability for the duration of the registry
    • Histology proven pancreatic carcinoma in any area of pancreas
    • Pancreatic tumor that can be treated by FUS
    • Willingness and ability to complete follow-up interviews

    • Exclusion Criteria:

    • Any disease, condition or surgery which would result in a contraindication to undergoing FUS therapy.
    • Clinical trials of pancreatic cancer not of focused ultrasound or related activities
    • Other non-pancreatic cancer clinical trials

    Collaborators and Investigators

    This is where you will find people and organizations involved with this study.

    • Navitas Clinical Research, Inc

    • PRINCIPAL_INVESTIGATOR: Joo Ha Hwang, MD, PhD, Stanford University

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available