Status:
SUSPENDED
High Intensity Focused Ultrasound Tumor Treatment for Pancreatic Cancer Pain
Lead Sponsor:
CMED HIFU Development Corporation
Conditions:
Pain
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00637364
Start Date
March 1 2008
Last Update
January 13 2009
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195