High Intensity Focused Ultrasound Tumor Treatment For Pancreatic Cancer Pain

Study Overview

High Intensity Focused Ultrasound Tumor Treatment for Pancreatic Cancer Pain

This is an open-label, non-randomized, single-center, therapeutic trial in patients with AJCC Stage III or IV pancreatic cancer with tumor related abdominal and/or back pain to evaluate the safety of high intensity focused ultrasound therapy using the FEP-BY02 HIFU system for palliation of pancreatic cancer-related pain. Patients meeting all eligibility criteria without any exclusion criteria will be offered an opportunity to participate in the study. After obtaining informed consent a baseline history, physical examination, laboratory studies, and any additional imaging studies needed will be performed. The major theoretic risk to the patient with this procedure is the development of acute pancreatitis. If acute pancreatitis were to develop, it should become clinically evident by day 3 following HIFU ablation. Therefore, the initial phase of this pilot study is designed to allow a sufficient interval between HIFU treatments to identify whether this theoretic risk will manifest clinically. Previous clinical experience in China suggests that HIFU of pancreatic tumors is safe without risk of developing severe acute pancreatitis. Patients treated with HIFU will have approximately 15-20% of the tumor volume treated per session. The first 5 patients (feasibility study) will receive their first HIFU treatment followed by a 3-5 day interval for observation. Following the feasibility study the results will be reviewed with the FDA. If no serious adverse events are encountered, and the FDA agrees with continuing the study, then the next 5 patients will be treated with an interval of 2-3 days between each treatment. If no serious adverse events are encountered in this group, then the next group of 5 patients will be treated at intervals of 1-2 days between each treatment.

N/A

Pain
Pancreatic Adenocarcinoma
Ductal Adenocarcinoma

PROCEDURE: High intensity focused ultrasound, HIFU

FEP-BY02-01
WIRB 20071832

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-03-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2009-01-12
First Submitted that Met QC Criteria 2008-03-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2009-01-13
First Posted (ESTIMATED) 2008-03-18	Results First Posted N/A	Last Verified 2009-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Safety of the FEP-BY02 HIFU system determined by the frequency and severity of adverse events (AEs) categorized and graded for severity according to the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE)		pre treatment, post treatment, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, 24 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age older than 18 years
Histology proven pancreatic ductal adenocarcinoma in the body or tail of the pancreas with a 1 cm margin of tissue to all named vessels and adjacent organs
AJCC stage III or IV pancreatic cancer based on imaging criteria (endoscopic ultrasound, CT scan, and/or MRI)
Presence of mid-abdominal pain or back pain (>=4 at its worst on Brief Pain Inventory) in the week prior to baseline evaluation or requiring any dose of opioid narcotic for pain relief
Pancreatic tumor that can be evaluated by RECIST criteria
Pancreatic tumor that can be imaged with transabdominal ultrasonography
Pancreatic tumors with an adequate window for the HIFU beam without intervening air or colon
No contraindications for CT/PET imaging
Karnofsky's performance status of 50% or greater
Life expectancy greater than 3 months
Normal coagulation profile (INR <1.6; platelet count >50,000)
American Society of Anesthesiologists (ASA) class =/<2, not including patient's diagnosis of pancreatic carcinoma
Normal serum uric acid, calcium, potassium, phosphate and creatinine values
Willingness and ability to complete follow-up interviews for 24 months following the last HIFU treatment

Previous pancreatic surgery or resection
Have had previous surgery to remove jaundice causing obstruction
Active malignancy (not including metastases) or history of other primary source of cancer other than pancreas except for basal cell carcinoma or carcinoma-in-situ of the cervix
Any other disease, condition or surgery which might confound HIFU therapy, including the requirement for the patient to remain still in the supine position for 90 minutes
Inability to image the pancreatic tumor with ultrasound
The presence of bone (e.g., ribs) in the path of the HIFU beam
The presence of colon in the path of the HIFU beam
Use of aspirin containing or aspirin-analog products, including herbal supplements that may decrease coagulation, within two weeks of first HIFU treatment
Currently a prisoner
Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia)
Pregnancy at time of enrollment, since this would contraindicate HIFU therapy
Participation in any other investigational drug, biologic or medical device study within the 30 days prior to the study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Joo Ha Hwang, MD, PhD, University of Washington

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record