High Intensity Focused Ultrasound Tumor Treatment for Pancreatic Cancer Pain - Full Text View

Sponsored by:	CMED HIFU Development Corporation
Information provided by:	CMED HIFU Development Corporation
ClinicalTrials.gov Identifier:	NCT00637364

Purpose

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.

Condition	Intervention	Phase
Pain Pancreatic Adenocarcinoma Ductal Adenocarcinoma	Procedure: High intensity focused ultrasound, HIFU	Phase I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Cancer Pancreatic Cancer Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Open Label, Non-Randomized, Single-Center, Therapeutic Trial Examining the Feasibility, Safety, and Efficacy of FEP-BY02, a High Intensity Focused Ultrasound Tumor Treatment Device, in Patients With Pancreatic Cancer Pain

Further study details as provided by CMED HIFU Development Corporation:

Primary Outcome Measures:

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) [ Time Frame: pre treatment, post treatment, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	5
Study Start Date:	March 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

The FEP-BY02 HIFU system uses extracorporeal generated high intensity ultrasound, focused on a tumor region of interest, to ablate tissue. A stand-alone B-mode ultrasound is used to locate and define the tumor region of interest. Once defined, the acoustic energy is delivered using a large aperture; fixed focus; sparse transducer array. The concentration of acoustic energy may result in thermal and/or mechanical bioeffects including tissue necrosis, apoptosis, and/or disruption (temporary or permanent) of normal cellular function within the targeted volume (such as nerve conduction).

The FEP-BY02 High Intensity Focused Ultrasound (HIFU) system is intended to ablate ductal adenocarcinoma of the pancreas with ultrasound-guided targeted delivery of focused ultrasound energy to effect thermal and/or mechanical bioeffects leading to ablation (destruction) of the targeted tumor tissue.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637364

Locations

United States, Washington
University of Washington
Seattle, Washington, United States, 98195

Sponsors and Collaborators

CMED HIFU Development Corporation

Investigators

Principal Investigator:

Joo Ha Hwang, MD, PhD

University of Washington

More Information

No publications provided

Responsible Party:	University of Washington ( Joo Ha Hwang, MD, PhD )
Study ID Numbers:	FEP-BY02-01, WIRB 20071832
Study First Received:	March 12, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00637364 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by CMED HIFU Development Corporation:

pain
pancreas
pancreatic cancer
pancreatic adenocarcinoma
ductal adenocarcinoma

Study placed in the following topic categories:

Digestive System Neoplasms
Skin Diseases
Pancreatic Neoplasms
Breast Neoplasms
Endocrine System Diseases
Pain
Pancrelipase
Carcinoma
Carcinoma, Ductal

Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Carcinoma, Ductal, Breast
Endocrinopathy
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Skin Diseases
Pancreatic Neoplasms
Breast Neoplasms
Endocrine System Diseases
Carcinoma
Carcinoma, Ductal
Neoplasms

Neoplasms by Site
Digestive System Diseases
Pancreatic Diseases
Carcinoma, Ductal, Breast
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009