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2012-11
2014-09
2014-09
5
NCT01698710
Massachusetts General Hospital
Massachusetts General Hospital
INTERVENTIONAL
Endoscopic Abraxane Injection Into Pancreatic Cysts
This research study is a pilot study. In this pilot study we are testing the safety of a procedure. "Investigational" means that the Albumin bound paclitaxel (Abraxane) is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved Abraxane injection for your type of medical condition. Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection of the cysts. As part of standard medical care, you will be undergoing a diagnostic endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the injection of the drug into the cyst cavity if your cyst is thought to be cancerous or precancerous. Cyst fluid will be analyzed for further diagnosis.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2012-10-01 | 2017-05-26 | 2017-05-26 |
2012-10-01 | 2017-05-26 | 2017-06-21 |
2012-10-03 | 2017-06-21 | 2014-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Albumin bound paclitaxel Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure. | DRUG: Albumin bound paclitaxel
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Frequency of Pancreatitis | Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis. | 3-10 months (median 6 months) after injection therapy |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts | The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study. | immediately after procedure |
| Size of Cystic Lesion | Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported. | 3-10 months (median 6 months) after injection therapy |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
