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

Focused Ultrasound Foundation

Status: Terminated

Conditions: Pancreatic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03724435

FUSREG001

Details and patient eligibility

About

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 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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

21 participants in 1 patient group

Pancreatic Cancer Participants

Description:

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