EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts
You will be asked to undergo some screening tests or procedures to find out if you can be in
the research study. Many of these tests and procedures are likely to be part of regular
cancer care and may be done even if it turns out that you do not take part in the research
study. If you have had some of these tests or procedures recently, they may or may not have
to be repeated. Screening tests include the following: medical history, performance status,
assessment of pancreatic cyst by CT, MRI or EUS, blood tests and a pregnancy test.
If these tests show that you are eligible to participate in the research study, you will
begin the study treatment. If you do not meet the eligibility criteria you will not be able
to participate in this research study.
As part of your medical care you will be undergoing an endoscopic procedure EUS-FNA
(Endoscopic Ultrasound Fine Needle Aspiration) in order to evaluate and evacuate the cyst
fluid. During the EUS-FNA and just after the cyst fluid aspiration, albumin bound paclitaxel
will be injected into the cyst cavity.
The study procedure (injection of drug into cyst cavity) takes place over 5 minutes during
the EUS-FNA. 2 days after the procedure you will receive a phone call from the research
coordinator to check on how you are feeling. 3 months after study procedure participants
will undergo a follow up CT to see what happened to the cyst. You will continue to have
routine follow up for your medical problems.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine frequency of pancreatitis after injection therapy
The primary endpoint of the study will be the determination of the safety of injection of albumin-bound paclitaxel. Safety of the procedure will be measured by the frequency of pancreatitis. Laboratory testing will be performed 2 days after procedure
William Brugge, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|