Suspended

EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts

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What is being tested

Albumin bound paclitaxel

Drug
Who is being recruted

Cysts+3

+ Digestive System Diseases

+ Neoplasms

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: June 21, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorMassachusetts General Hospital
Last updated: June 21, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CystsDigestive System DiseasesNeoplasmsPancreatic DiseasesPancreatic CystPrecancerous Conditions

Criteria

3 inclusion criteria required to participate
Baseline CT within 6 months of enrollment

Mucinous cysts (premalignant or malignant cysts of the pancreas)

Normal organ and marrow function

4 exclusion criteria prevent from participating
Acute active pancreatitis

Complicated pancreatic cysts

Pregnant or breastfeeding

Subjects who do not speak English

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers