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

NCT ID: NCT05010226

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2026-09-30

Brief Summary

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.

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.

Conditions

Pancreatic Cancer; Focused Ultrasound

Study Design

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

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai-Wen Huang, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Central Contacts

Kai-Wen Huang, M.D. Ph.D

Role: CONTACT

skywing@ntuh.gov.tw

886-2-23123456 ext. 66144

Other Identifiers

202007081RINB

Identifier Type: -

Identifier Source: org_study_id