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

Sponsor

CMED HIFU Development Corporation (Industry)

Overall Status

Suspended

CT.gov ID

NCT00637364

Collaborator

(none)

Enrollment

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Pancreatic Adenocarcinoma Ductal Adenocarcinoma	Procedure: High intensity focused ultrasound, HIFU	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2008

Anticipated Primary Completion Date :

Jul 1, 2010

Outcome Measures

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) [pre treatment, post treatment, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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