Pancreas AdenocarcinomaNCT05161013
A Proof-of-Concept Study Evaluating LINFU™
A study testing LINFU™ in people with Pancreas Adenocarcinoma and Dysplasia, run by Adenocyte, LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreas Adenocarcinoma, Dysplasia
- What is being tested?
- LINFU™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2021to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both males and females will be enrolled and must be at least 18 years of age and under age of 90
- Patients at high risk of developing a pancreatic malignancy.
- Patients undergoing EUS or receiving an MRI scan as part of their screening.
- Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
Who cannot join
- Patient under the age of 18 and over the age 90
- Patients undergoing FNA
- Contraindications to EUS as determined by study investigators.
- Patient with uncorrectable coagulopathy
- Patient that cannot undergo anesthesia due to cardio- pulmonary contraindication as deemed by the anesthesiologist
- Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Gastroenterology Associates of Sarasota
Sarasota, Florida, 34239
About this study
Official title: A Proof-of-Concept Study Evaluating LINFU™: A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into the Pancreatic Fluid for the Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC)
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.
Read the detailed description
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
- Once the participant is sedated or under anesthesia, low intensity non-focused ultrasound excitation of the pancreas will be implemented. This means the sound waves from the ultrasound on the top of the stomach will be used to stimulate the pancreas to release juice.
- During the ultrasound, the Investigator will administer Lumason through a vein in the participant's arm (IV). Lumason is a contrast agent that was frequently used to create bubbles that allows a better visualization of images. In this study, Lumason will be used to create bubbles and possibly increase the number of pancreatic cells collected for the study.
- After 25 minutes of ultrasound, the participant will receive an IV dose of secretin over 1 minute. Naturally, secretin is a hormone released into the bloodstream by a part of the small intestine, namely duodenum, (especially in response to acidity) to stimulate secretion by the liver and pancreas. In this study, Secretin is used to increase the number of pancreatic cell excretion to maximize the number of cells collected.
- The participant will then undergo EGD (insertion of a tube down the throat and past the stomach). EGD stands for esophagogastroduodenoscopy. The Investigator who is doing EGD will discuss all risks and explain how the procedure will be done.
- The pancreatic juice will be collected immediately. About 15 minutes after the EGD procedure has begun, a second dose of secretin will be administered.
- The pancreatic juice will continue to be collected for a total of 30 minutes.
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.
- Conditions
- Pancreas Adenocarcinoma, Dysplasia
- Being tested
- LINFU™
- Keywords
- Pancreatic Neoplasm, Pancreatic Cancer, Early detection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: LINFU™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start21 Oct 2021
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients at high risk of developing pancreatic cancer
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adenocyte, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Corbett, MD, FASGE, Principal investigator, Suncoast Endoscopy of Sarasota (a division of Florida Digestive Health Specialists)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161013
- Sponsor's protocol ID
- Adenocyte 111
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Study Evaluating LINFU™: A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into the Pancreatic Fluid for the Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC)
- ClinicalTrials.gov ID
- NCT05161013
- Acronym / sponsor ID
- Adenocyte 111
- Conditions
- Pancreas Adenocarcinoma, Dysplasia
- Keywords
- Pancreatic Neoplasm, Pancreatic Cancer, Early detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Adenocyte, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Once the participant is sedated or under anesthesia, low intensity non-focused ultrasound excitation of the pancreas will be implemented. This means the sound waves from the ultrasound on the top of the stomach will be used to stimulate the pancreas to release juice.
- During the ultrasound, the Investigator will administer Lumason through a vein in the participant's arm (IV). Lumason is a contrast agent that was frequently used to create bubbles that allows a better visualization of images. In this study, Lumason will be used to create bubbles and possibly increase the number of pancreatic cells collected for the study.
- After 25 minutes of ultrasound, the participant will receive an IV dose of secretin over 1 minute. Naturally, secretin is a hormone released into the bloodstream by a part of the small intestine, namely duodenum, (especially in response to acidity) to stimulate secretion by the liver and pancreas. In this study, Secretin is used to increase the number of pancreatic cell excretion to maximize the number of cells collected.
- The participant will then undergo EGD (insertion of a tube down the throat and past the stomach). EGD stands for esophagogastroduodenoscopy. The Investigator who is doing EGD will discuss all risks and explain how the procedure will be done.
- The pancreatic juice will be collected immediately. About 15 minutes after the EGD procedure has begun, a second dose of secretin will be administered.
- The pancreatic juice will continue to be collected for a total of 30 minutes.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients at high risk of developing pancreatic cancer
| Arm | Type | Receives |
|---|---|---|
| The LINFU™ test | Experimental | Diagnostic Test: LINFU™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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both males and females will be enrolled and must be at least 18 years of age and under age of 90
- Patients at high risk of developing a pancreatic malignancy.
- Patients undergoing EUS or receiving an MRI scan as part of their screening.
- Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LINFU™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. | Diagnostic test | The LINFU™ test |
Primary outcome
Does LINFU™ yield an adequate number of cells that can be used to help diagnose pancreatic precancers and cancers?
Time frame: 4 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Corbett, MD, FASGE principal investigator
Suncoast Endoscopy of Sarasota (a division of Florida Digestive Health Specialists)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LINFU™ in people with Pancreas Adenocarcinoma and Dysplasia, run by Adenocyte, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does LINFU™ yield an adequate number of cells that can be used to help diagnose pancreatic precancers and cancers? (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.