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

NCT03724435 | Terminated

• 1 other identifier: FUSREG001
• Study Type: observational
• Target: 21
• Locations: 4 countries
• Sites: 4

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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; focused ultrasound

Outcome Measures

Primary Outcomes (1)

• Survival

  Time until the occurence of death

  1 year

Other Outcomes (4)

• Pain Related to Pancreatic Cancer

  Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months

• Performance Status

  Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months

• Clinical Benefit Response (CBR)

  Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months

Study Arms (1)

Pancreatic Cancer Participants

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Focused Ultrasound Foundation: lead
• Navitas Clinical Research, Inc: collaborator

Study Sites (4)

Medical University of Pleven

Pleven, Bulgaria

Location

Seoul National University

Seoul, South Korea

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Oxford University Hospital

Headington, Oxford, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Joo Ha Hwang, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Joan Vidal-Jove, MD, PhD

  Hospital Universitario Mútua Terrassa

  PRINCIPAL INVESTIGATOR

• Tim Meakem, MD

  Focused Ultrasound Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: October 30, 2018
• Study Start: December 6, 2019
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

KR (1); GB (1); BU (1); TW (1)