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

Overview

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.

Full Title of Study: “ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR – an InternAtional RegistrY”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2020

Detailed Description

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

Arms, Groups and Cohorts

  • Pancreatic Cancer Participants
    • No intervention will be administered. Assessments are performed as standard of care.

Clinical Trial Outcome Measures

Primary Measures

  • Survival
    • Time Frame: 1 year
    • Time until the occurence of death

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Focused Ultrasound Foundation
  • Collaborator
    • KAI Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joo Ha Hwang, MD, PhD, Principal Investigator, Stanford University
    • Franco Orsi, MD, Principal Investigator, Istituto Europeo di Oncologia
    • Tim Meakem, MD, Study Director, Focused Ultrasound Foundation
  • Overall Contact(s)
    • Tanisha Brown-Caines, 301-770-2730, TCaines@kai-research.com

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