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Endoscopic Abraxane Injection Into Pancreatic Cysts

This study has been terminated.
(expiration of IRB approval)
Sponsor:
Information provided by (Responsible Party):
William R. Brugge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01698710
First received: October 1, 2012
Last updated: May 26, 2017
Last verified: September 2014
October 1, 2012
May 26, 2017
November 2012
September 2014   (Final data collection date for primary outcome measure)
Frequency of Pancreatitis [ Time Frame: 3-10 months (median 6 months) after injection therapy ]
Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.
Determine frequency of pancreatitis after injection therapy [ Time Frame: 2 years ]
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
Complete list of historical versions of study NCT01698710 on ClinicalTrials.gov Archive Site
  • Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts [ Time Frame: immediately after procedure ]
    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.
  • Size of Cystic Lesion [ Time Frame: 3-10 months (median 6 months) after injection therapy ]
    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.
  • Determine feasibility of EUS guided injection of albumin-bound paclitaxel into pancreatic cysts [ Time Frame: 2 years ]

    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.

    Total procedure time will be recorded. If the cyst injection and lavage take more than 10 minutes, we will consider this a failure.

  • Determine the decrease in size of the cystic lesion at 3 months using CT scanning [ Time Frame: 2 years ]
    Determine the decrease in size of the cystic lesion at 3 months using CT scanning
Not Provided
Not Provided
 
Endoscopic Abraxane Injection Into Pancreatic Cysts
EUS Guided Injection of Albumin Bound Paclitaxel 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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cysts
Drug: Albumin bound paclitaxel
Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Other Name: Abraxane
Experimental: Albumin bound paclitaxel
Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Intervention: Drug: Albumin bound paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mucinous cysts (premalignant or malignant cysts of the pancreas)
  • Normal organ and marrow function
  • Baseline CT within 6 months of enrollment

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Acute active pancreatitis
  • Complicated pancreatic cysts
  • Subjects who do not speak English
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01698710
12-178
Yes
Not Provided
Not Provided
William R. Brugge, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: William Brugge, MD Massachusetts General Hospital
Massachusetts General Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP