- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01698710
Endoscopic Abraxane Injection Into Pancreatic Cysts
EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3-10 months (median 6 months) after injection therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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immediately after procedure
|
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.
|
3-10 months (median 6 months) after injection therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Brugge, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Pathological Conditions, Anatomical
- Pancreatic Diseases
- Pancreatic Cyst
- Cysts
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- 12-178
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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