Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CMED HIFU Development Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
