Endoscopic Abraxane Injection Into Pancreatic Cysts

Status: Recruiting
Phase: N/A
Diagnosis: Gastrointestinal Malignancies
NCT ID: NCT01698710 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-178

 

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.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
William Brugge, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

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
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