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

March 14, 2024 updated by: Focused Ultrasound Foundation

ARRAY: 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.

Study Overview

Status

Terminated

Conditions

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

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

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

Study Contact

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Medical University of Pleven
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University
  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital
  • United Kingdom
    • Oxford
      • Headington, Oxford, United Kingdom
        • Oxford University Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The registry population will be drawn from patients who have been diagnosed with pancreatic cancer and are eligible for FUS therapy. Participants are allowed to receive standard-of-care treatment, including chemotherapy, radiation therapy, and best supportive care. Participants being treated in another FUS clinical trial may be included in this registry.

Description

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

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 1 year
Time until the occurence of death
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Related to Pancreatic Cancer
Time Frame: Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
The proportion achieving a 2 point reduction or greater will be assessed at each time point and across time using the Brief Pain Inventory (Short Form). Pain will be rated from 0 (no pain) to 10 (pain as a bad as can imagine) .
Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
Performance Status
Time Frame: Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
Improvement in performance status for a period of at least 4 consecutive weeks without showing any sustained worsening.
Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
Clinical Benefit Response (CBR)
Time Frame: Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
The proportion of participants with a CBR will be measured at each follow-up time point.
Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
Impact on Quality of Life and Cost
Time Frame: Baseline, Day 1, Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
Standardized instrument to measure of health-related quality of life.
Baseline, Day 1, Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months

Collaborators and Investigators

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

Sponsor

Focused Ultrasound Foundation

Collaborators

Navitas Clinical Research, Inc

Investigators

  • Principal Investigator: Joo Ha Hwang, MD, PhD, Stanford University
  • Principal Investigator: Joan Vidal-Jove, MD, PhD, Hospital Universitario Mutua Terrassa
  • Study Director: Tim Meakem, MD, Focused Ultrasound Foundation

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 Major Dates

Study Start (Actual)

December 6, 2019

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

August 31, 2018

First Submitted That Met QC Criteria

October 26, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUSREG001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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