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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer; Focused Ultrasound

Detailed Description

This is a single-group, multi-center, observational log-in study. Patients will be screened for clinically diagnosed pancreatic cancer and are scheduled to receive focused ultrasound therapy at National Taiwan University Hospital to determine their eligibility for participation. After confirming that the patient has agreed, the patient will be followed up for 12 months to observe safety, tumor response, changes in clinical manifestations, and changes in the process of focused ultrasound treatment and quality of life after treatment. The overall survival and disease progression time will be tracked within 3 days before and after the 7th day of focused ultrasound treatment to death or 12 months, with the earlier occurrence being the priority. The patient's survival status will be tracked for 1 year.

The physical condition will be evaluated by laboratory tests during the baseline screening, the next day after treatment, and 7 days, 14 days, 1 month, 2 months, 3 months, 6 months, and 12 months. Including blood tests, serum biochemical tests, tumor indicators, etc.; quality of life assessment, including pain index score (VAS) and SF-36 life scale (The MOS item short-form health survey, SF-36) will be one after treatment Evaluation starts in the following month; MRI imaging examination, all examinations, and treatments have been carried out in the 201701032DIPD clinical trial case. This case is only an observational clinical trial case for data registration.

The baseline screening before treatment will be carried out between the -3 days and the 0 days before the treatment. The overall survival time (OS) will be tracked for 1 year; the time to disease progression (TTP) and progression-free survival (PFS) will continue to be tracked during the trial until the patient dies or undergoes other curative procedures (tracking should be carried out every 3 months) once). Concomitant drugs/treatments and adverse events will be tracked continuously during the trial period.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Kai-Wen Huang, M.D. Ph.D; Phone Number: 66144 886-2-23123456; Email: skywing@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The registry will be implemented at approximately 10 sites internationally. In order to achieve the target registry population of 30 participants over 12 months in the NTUH site, participants who receive focused ultrasound for pancreatic cancer. Participant enrollment will be evaluated on a site by site basis throughout the enrollment period to provide diversity of participant and system representation.

Description

Inclusion Criteria:

• In order to be eligible to participate in this registry, an individual must meet all of the following criteria:

  1. 20 years and older
  2. Provision of signed and dated informed consent form
  3. Stated willingness to comply with all registry procedures and availability for the duration of the registry
  4. Histology proven pancreatic carcinoma in any area of pancreas
  5. Pancreatic tumor that can be treated by FUS
  6. Willingness and ability to complete follow-up interviews
  7. Patients have agreed to participate in the clinical trial 201701032DIPD and were scheduled to receive FUS therapy in our hospital

Exclusion Criteria:

• An individual who meets any of the following criteria will be excluded from participation in this registry:

  1. Any disease, condition or surgery which would result in a contraindication to undergoing FUS therapy.
  2. Clinical trials of pancreatic cancer not of focused ultrasound or related activities

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain related to pancreatic cancer	Brief Pain Inventory from 0 (no pain) to 10 (pain as a bad as can imagine)	after high focused ultrasound treatment, an average of 1 month
To observe the efficacy of local tumor ablation	the assessment of the tumor burden after high focused ultrasound treatment	after high focused ultrasound treatment, an average of 1 month
The effect of local tumor ablation	time-to-progression	over 12 months
To observe the survival rate	overall survival (OS)	over 12 months
To observe the progression-free survival rate	observation of the progression-free survival	over 12 months
To evaluate clinical benefit response (CBR)	The proportion of participants with a CBR will be measured at each follow-up time point	over 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on Quality of Life and Cost	Standardized instrument to measure of health-related quality of life.	over 12 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Kai-Wen Huang, M.D. Ph.D, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): September 1, 2026

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 202007081RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No