A Pilot Study of the Effects of Contrast Enhanced Endoscopic Ultrasound on Determining Vascular Involvement in Pancreatic Lesions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Vermont.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
James Hebert, University of Vermont
ClinicalTrials.gov Identifier:
NCT01526590
First received: January 10, 2012
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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 Intervention
Pancreatic Tumors
Drug: Definity Contrast

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Lesion Margin [ Time Frame: Up to six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sequence of filling [ Time Frame: Up to six months ] [ Designated as safety issue: No ]
  • Pattern of Perfusion [ Time Frame: Up to six months ] [ Designated as safety issue: No ]
  • Degree of venous washout [ Time Frame: Up to six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526590

Locations
United States, Vermont
Fletcher Allen Healthcare Not yet recruiting
Burlington, Vermont, United States, 05401
Contact: Paul Taheri    802-656-5040    paul.taheri@vtmednet.org   
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: James Hebert, M.D. University of Vermont/Fletcher Allen Healthcare
  More Information

No publications provided

Responsible Party: James Hebert, Mackay-Page Professor of Surgery, University of Vermont
ClinicalTrials.gov Identifier: NCT01526590     History of Changes
Other Study ID Numbers: CHRMS_M11-203
Study First Received: January 10, 2012
Last Updated: July 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Definity
Perflutren
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014