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High Intensity Focused Ultrasound Tumor Treatment for Pancreatic Cancer Pain (HIFU Pancreas)

Primary Purpose

Pain, Pancreatic Adenocarcinoma, Ductal Adenocarcinoma

Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
High intensity focused ultrasound, HIFU
Sponsored by
CMED HIFU Development Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, pancreas, pancreatic cancer, pancreatic adenocarcinoma, ductal adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Outcomes

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)

Secondary Outcome Measures

Full Information

First Posted
March 12, 2008
Last Updated
January 12, 2009
Sponsor
CMED HIFU Development Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00637364
Brief Title
High Intensity Focused Ultrasound Tumor Treatment for Pancreatic Cancer Pain
Acronym
HIFU Pancreas
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Suspended
Why Stopped
Sponsor is not proceeding with USA human trial at this time
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
CMED HIFU Development Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Pancreatic Adenocarcinoma, Ductal Adenocarcinoma
Keywords
pain, pancreas, pancreatic cancer, pancreatic adenocarcinoma, ductal adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
High intensity focused ultrasound, HIFU
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo Ha Hwang, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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High Intensity Focused Ultrasound Tumor Treatment for Pancreatic Cancer Pain

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