Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry
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|ClinicalTrials.gov Identifier: NCT05010226|
Recruitment Status : Not yet recruiting
First Posted : August 18, 2021
Last Update Posted : August 18, 2021
|Condition or disease|
|Pancreatic Cancer Focused Ultrasound|
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|
|Estimated Enrollment :||30 participants|
|Official Title:||Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry|
|Estimated Study Start Date :||September 2021|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||September 2026|
- Pain related to pancreatic cancer [ Time Frame: after high focused ultrasound treatment, an average of 1 month ]Brief Pain Inventory from 0 (no pain) to 10 (pain as a bad as can imagine)
- To observe the efficacy of local tumor ablation [ Time Frame: after high focused ultrasound treatment, an average of 1 month ]the assessment of the tumor burden after high focused ultrasound treatment
- The effect of local tumor ablation [ Time Frame: over 12 months ]time-to-progression
- To observe the survival rate [ Time Frame: over 12 months ]overall survival (OS)
- To observe the progression-free survival rate [ Time Frame: over 12 months ]observation of the progression-free survival
- To evaluate clinical benefit response (CBR) [ Time Frame: over 12 months ]The proportion of participants with a CBR will be measured at each follow-up time point
- Impact on Quality of Life and Cost [ Time Frame: over 12 months ]Standardized instrument to measure of health-related quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05010226
|Contact: Kai-Wen Huang, M.D. Ph.D||886-2-23123456 ext firstname.lastname@example.org|
|Principal Investigator:||Kai-Wen Huang, M.D. Ph.D||National Taiwan University Hospital|