An interventional study of Definity Contrast in Pancreatic Tumors, sponsored by University of Vermont. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-04.
Sponsored by University of Vermont · Not applicable, Interventional, and Diagnostic
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.
CT Scan of the abdomen - Standard Therapy
a. The standard of care is that patients in question of pancreatic lesions undergo CT scanning. After a CT scan, if it appears that the pancreatic mass may be resectable, the standard protocol is to look at the pancreas while the patient is sedated with endoscopic ultrasound for diagnostic tissue sampling and further staging. For this reason, the endoscopist will not be blinded to the CT scan because it is the standard of care that they interpret the results of the EUS with that information.
Consent for Endoscopic Ultrasound (EUS) - Standard Therapy
a. Before being sedated and having endoscopic ultrasound, all patients are informed about the risks of the procedure, alternatives, and what will be done. The patients who decide to undergo endoscopic ultrasound will sign a consent form. Our goal is to enroll 30 patients (This number is limited by both the amount of contrast received from Lantheus and the number of patients typically seen in a year. Ideally we will enroll as many as possible for the purposes of power).
Consent for Contrast Enhanced Endoscopic Ultrasound (CE-EUS) -- Performed exclusively for research purposes
EUS - Standard of Care
EUS Questionnaire - Preformed exclusively for research purposes. Duration less than one minute.
CE-EUS - Experimental Procedure performed exclusively for research purposes
a. Dosing of Contrast - procedure performed exclusively for research purposes i. While the patient is still sedated and before tissue sampling, the experimental aspect of the procedure will begin. At this time, they 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. A saline flush will follow the injection of the contrast and a timer will be started. The remaining contrast will be properly disposed of in a sharps container.
b. Recording of CE-EUS images - procedure performed exclusively for research purposes. Duration 3-4 minutes i. The endoscopist will perform an additional reading with the contrast and record a 3-4 minute segment for review later using the harmonic mode of the ultrasound probe at a mechanical index of 0.3. The mechanical index may need to be be optimized, however a previous study found 0.3 to be optimal. Aspects that will be analyzed later are sequence of filling (central vs peripheral), timing (arterial [0-30s], venous [60-180s], post-venous/equilibrium phase [>180s]), pattern of perfusion (homogenous vs heterogenous, and with or without defect) and degree of venous washout. After the experimental portion of the procedure the endoscopist will fill out a form (see attached) to record their impressions of the characteristics of the tumor with contrast. The images will be saved for further comparison with the CT scan and the pathology results at a later time.
FNA - Standard of care (if previously decided upon)
a. If it was determined after the normal EUS but before the CE-EUS that the patient needed tissue sampling, the patient will then undergo the sampling in the standard fashion. If the patient was not to receive tissue sampling, the exam would be over. When the exam is finished the endoscopist will fill out the remaining questionnaire while the patient recovers.
Patient transport to recovery room - Standard of Care
Radiologist's Interpretation - Research purposes only
a. After CE-EUS and EUS, the images will be randomly ordered and interpreted by a radiologist. An excel sheet will be made and the studies will be placed into three separate blocks in chronological order Participant 1-10, 11-20, and 21-30. In a separate column a random number generator will order the first block of 1-10's EUS into a random order for and then again a different random order for CE-EUS. The radiologist will fill out the attached questionnaire. The Surgeon will be blinded to these readings as they are for research purposes only and not the standard of care.
Surgery - Standard of Care with questionnaire after the procedure for research purposes
a. The surgeon will record their impressions of the vascular involvement of the tumor on the attached questionnaire after the surgery.
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Exclusion Criteria:
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.
Also known as: Definity ultrasound contrast
Lesion Margin
Time frame: Up to six months
Sequence of filling
Time frame: Up to six months
Pattern of Perfusion
Time frame: Up to six months
Degree of venous washout
Time frame: Up to six months
This study is withdrawn, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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