Contrast Enhanced Endoscopic Ultrasound for Vascular Involvement in Pancreatic Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526590
Recruitment Status : Withdrawn (Lack of support)
First Posted : February 6, 2012
Last Update Posted : June 4, 2015
Information provided by (Responsible Party):
James Hebert, University of Vermont

Brief Summary:

In the US, pancreas cancer is the fifth leading cause of cancer related deaths. It was estimated to have taken 36,800 lives in 2010. Unfortunately, curing pancreatic cancer requires surgical removal. Surgical removal of the pancreas is associated with high morbidity and mortality, as well as high rates of complications. One way to aid surgeons in removing pancreatic tumors is by providing them with a good idea of where the tumor is located and what surrounding structures are involved. This currently happens through many different modalities of imaging; usually computed tomography (CT) and endoscopic ultrasound. Even with these forms of imaging (and sometimes others), surgeons will occasionally open a patient and find that the tumor cannot be removed due to its involvement with surrounding structures.

One way to avoid potentially unnecessary procedures or to help a surgeon navigate this delicate procedure would be to provide more detailed information about the tumor. Several of the techniques currently used to image the body have rapidly advanced over recent years. Typical advancements come through better resolution of the images or contrast to enhance desired parts of the images. Ultrasound has not seen such a two pronged advance. Ultrasound has seen substantial advances in resolution to enhance picture quality, but contrast has not been used clinically to assess pancreatic masses whereas it is for cardiologists to use contrast to look at potential defects in the heart.

The contrast that is used with ultrasound is different from that of CT scans. CT scanners use a dye that can be potentially hazardous. This dye can lead to serious kidney damage in some patients. Ultrasound contrast, on the other hand, is made of small micro bubbles filled with a harmless gas. Because of the way ultrasound works, these micro bubbles reflect the sound waves differently than the surrounding tissue and thus provide contrast between normal tissue and abnormal tissue. The contrast used in this study, Definity, and is the same contrast used by Cardiologists.

The CE-EUS will be used for research purposes only and will not be used for any clinical decision making. The surgeon will be blinded to the results of the research CE-EUS. The investigators will compare the research pre-operative contrast enhanced endoscopic ultrasounds images with already completed standard-of-care CT scans, the actual pancreatic involvement seen in surgery and the pathology reports.

Condition or disease Intervention/treatment Phase
Pancreatic Tumors Drug: Definity Contrast Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of the Effects of Contrast Enhanced Endoscopic Ultrasound on Determining Vascular Involvement in Pancreatic Lesions
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Ultrasound
Drug Information available for: Perflutren
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Definity
Patients enrolled in the study will undergo contrast enhanced endoscopic ultrasound of the pancreas with Definity contrast after they have undergone their standard of care endoscopic ultrasound of the pancreas.
Drug: Definity Contrast
While the patient is still sedated from their EUS and before tissue sampling, the patient will receive a dose of Definity intravenously through their peripheral IV access after being agitated. The dose of Definity will be 10 microliters/kg given in one to two doses, and will not exceed 2cc.
Other Name: Definity ultrasound contrast

Primary Outcome Measures :
  1. Lesion Margin [ Time Frame: Up to six months ]

Secondary Outcome Measures :
  1. Sequence of filling [ Time Frame: Up to six months ]
  2. Pattern of Perfusion [ Time Frame: Up to six months ]
  3. Degree of venous washout [ Time Frame: Up to six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient with pancreatic lesion undergoing EUS for diagnosis and pre-operative assessment.

Exclusion Criteria:

  • Pregnant women, breastfeeding women and individuals with metastatic lesions on CT.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526590

United States, Vermont
Fletcher Allen Healthcare
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Principal Investigator: James Hebert, M.D. University of Vermont/Fletcher Allen Healthcare

Responsible Party: James Hebert, Mackay-Page Professor of Surgery, University of Vermont Identifier: NCT01526590     History of Changes
Other Study ID Numbers: CHRMS_M11-203
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases