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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Pain, Pancreatic Adenocarcinoma, Ductal Adenocarcinoma

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Joo Ha Hwang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Food and Drug Administration

Study ID:

FEP-BY02-01

NCT ID:

NCT00637364

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Pain
  • Pancreatic Adenocarcinoma
  • Ductal Adenocarcinoma
  • pain
  • pancreas
  • pancreatic cancer
  • pancreatic adenocarcinoma
  • ductal adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Ductal, Breast

Name

Location

University of WashingtonSeattle, Washington  98195