Contrast Enhanced Endoscopic Ultrasound for Vascular Involvement in Pancreatic Lesions

NCT01526590 | Withdrawn

• 1 other identifier: CHRMS_M11-203
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Tumors

Outcome Measures

Primary Outcomes (1)

• Lesion Margin

  Up to six months

Secondary Outcomes (3)

• Sequence of filling

  Up to six months

• Pattern of Perfusion

  Up to six months

• Degree of venous washout

  Up to six months

Study Arms (1)

Definity

EXPERIMENTAL

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

Interventions

Definity Contrast DRUG

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.

Also known as: Definity ultrasound contrast

Definity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

Fletcher Allen Healthcare

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• James Hebert, M.D.

  University of Vermont/Fletcher Allen Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mackay-Page Professor of Surgery

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: February 6, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

US (1)