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The purpose of this research study is to study a method to detect pancreatic precancer and cancer (ductal adenocarcinoma) using ultrasound technology in those who are at significantly increased risk for developing pancreatic cancer. The LINFU™ Technique is done by analysis of pancreatic fluid collected with the help of ultrasound. This is an investigational way to detect pancreatic precancers and ductal adenocarcinoma.
Patients will undergo collection of pancreatic fluid by the LINFU™ Technique as part of this study. This procedure takes about 30-45 minutes. The details for the procedure are listed below.
LINFU™ Technique
The results of the LINFU technique will be provided to the investigator to help guide medical care. This is an experimental technique so participants won't receive the results. Participants will undergo clinical diagnostic procedures including EUS (endoscopic ultrasound) and/or MRI as part of the standard medical care and evaluation for pancreatic cancer. These procedures are not part of the study and the Investigator has already determined that these tests are required.
Participants will be called 24 hours after the study procedure and 30 days after the procedure to see if any symptoms of pancreatitis (inflammation of the pancreas have developed). If so, participants will be asked to come back to the clinic for further evaluation as would be done as part of the standard medical care. In addition, participants will have blood tests before the LINFU procedure and this will be repeated 24hours after the procedure. The blood tests will measure lipase levels to make sure there was no injury to the pancreas.
Any identifiable private information or specimens collected and/or used for the purposes of this research will not be used or distributed for future research studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The LINFU™ test | Experimental | LINFU™ to increase sensitivity of pancreatic juice cytology LINFU™ consists of analysis of pancreatic fluid collected with the help of low intensity non-focused ultrasound excitation of the pancreas. Lumason, will be used to create bubbles and possibly increase the number of pancreatic cell we collect for the study. Secretin is also used to increase the number of pancreatic cell excretion to maximize the number of cells collected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LINFU™ | Diagnostic Test | A method to detect pancreatic cancer (ductal adenocarcinoma) using ultrasound technology in those who are at significantly increased risk for developing pancreatic cancer. LINFU™ involves analysis of pancreatic fluid collected. |
| Measure | Description | Time Frame |
|---|---|---|
| Does LINFU™ yield an adequate number of cells that can be used to help diagnose pancreatic precancers and cancers? | The cells obtained from all 10 patients undergoing LINFU™ will be analyzed microscopically and counted by a pathologist for adequacy of pancreatic cellular yield. For a LINFU test to be considered adequate, 100 well-preserved ductal cells per patient must be counted under the microscope. Cellularity of >50 or <100 cells per patient would be interpreted as "limited but adequate" and cellularity <50 cells is unsatisfactory for adequacy. | 4 months |
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Inclusion criteria
Exclusion criteria
Patient under the age of 18 and over the age 90
Patients undergoing FNA
Contraindications to EUS as determined by study investigators.
Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium
Pregnant females will be excluded.
Patient that is unable to provide informed consent
Patient with known allergy to Lumason or Secretin
Patients with an elevated baseline lipase level
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| Name | Affiliation | Role |
|---|---|---|
| Scott Corbett, MD, FASGE | Suncoast Endoscopy of Sarasota (a division of Florida Digestive Health Specialists) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Associates of Sarasota | Sarasota | Florida | 34239 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Patients at high risk of developing pancreatic cancer
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |