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

NCT ID: NCT03724435

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-06
• Study Completion Date: 2023-11-30

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

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pancreatic Cancer Participants

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Navitas Clinical Research, Inc

UNKNOWN

Sponsor Role: collaborator

Focused Ultrasound Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joo Ha Hwang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Joan Vidal-Jove, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Mútua Terrassa

Tim Meakem, MD

Role: STUDY_DIRECTOR

Focused Ultrasound Foundation

Locations

Medical University of Pleven

Pleven, , Bulgaria

Seoul National University

Seoul, , South Korea

National Taiwan University Hospital

Taipei, , Taiwan

Oxford University Hospital

Headington, Oxford, United Kingdom

Countries

Bulgaria; South Korea; Taiwan; United Kingdom

Other Identifiers

FUSREG001

Identifier Type: -

Identifier Source: org_study_id