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

Terminated

• Conditions: Pancreatic Cancer

• Registration Number: NCT03724435
• Lead Sponsor: Focused Ultrasound Foundation

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-10-26
• Study First Posted: 2018-10-30
• Study Start: 2019-12-06
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	1 year	Time until the occurence of death

Trial Locations

Locations (4)

Oxford University Hospital; 🇬🇧 Headington, Oxford, United Kingdom

Medical University of Pleven; 🇧🇬 Pleven, Bulgaria

Seoul National University; 🇰🇷 Seoul, Korea, Republic of

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan