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
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