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

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ClinicalTrials.gov Identifier: NCT03724435
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : June 29, 2022
Navitas Clinical Research, Inc
Information provided by (Responsible Party):
Focused Ultrasound Foundation

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.

Condition or disease
Pancreatic Cancer

Detailed 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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR - an InternAtional RegistrY
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Survival [ Time Frame: 1 year ]
    Time until the occurence of death

Other Outcome Measures:
  1. Pain Related to Pancreatic Cancer [ Time Frame: Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months ]
    The proportion achieving a 2 point reduction or greater will be assessed at each time point and across time using the Brief Pain Inventory (Short Form). Pain will be rated from 0 (no pain) to 10 (pain as a bad as can imagine) .

  2. Performance Status [ Time Frame: Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months ]
    Improvement in performance status for a period of at least 4 consecutive weeks without showing any sustained worsening.

  3. Clinical Benefit Response (CBR) [ Time Frame: Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months ]
    The proportion of participants with a CBR will be measured at each follow-up time point.

  4. Impact on Quality of Life and Cost [ Time Frame: Baseline, Day 1, Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months ]
    Standardized instrument to measure of health-related quality of life.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

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): NCT03724435

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Contact: Sarah Lawrence 301-338-0912 ext 831 NCR_PCA_Registry@navitaslifesciences.com

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Medical University of Pleven Recruiting
Pleven, Bulgaria
Contact: Dobromir Dimitrov       dobri_dimitrov@abv.bg   
Korea, Republic of
Seoul National University Recruiting
Seoul, Korea, Republic of
Contact: Jae-Young Lee       leejy4u@snu.ac.kr   
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Kai-Wen Huang       skyntuh@gmail.com   
United Kingdom
Oxford University Hospital Recruiting
Headington, Oxford, United Kingdom
Contact: Srikanth Reddy, FRCS, PhD       Srikanth.Reddy@ouh.nhs.uk   
Sponsors and Collaborators
Focused Ultrasound Foundation
Navitas Clinical Research, Inc
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Principal Investigator: Joo Ha Hwang, MD, PhD Stanford University
Principal Investigator: Joan Vidal-Jove, MD, PhD Hospital Universitario Mútua Terrassa
Study Director: Tim Meakem, MD Focused Ultrasound Foundation
Additional Information:

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Responsible Party: Focused Ultrasound Foundation
ClinicalTrials.gov Identifier: NCT03724435    
Other Study ID Numbers: FUSREG001
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Focused Ultrasound Foundation:
pancreatic cancer
focused ultrasound
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases