Pancreatic CancerNCT06276803
The LINFU® U.S. Registry for the in the General Population Without Risk Factors
An observational study of Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Adenocyte, LLC.
Trial summary
Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions.. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Pancreatic Dysplasia
- What is being tested?
- LINFU®
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 15 Dec 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients who do not exhibit any symptoms of PDAC, do not have an abnormal imaging study suggestive of PDAC and who do not have risk factors which increase the risk of developing PDAC.
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, who in the opinion of the Investigator, do not exhibit any symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc.
- Patients, who in the opinion of the Investigator, do not have an abnormal imaging study suggestive of PDAC
- Patients, who in the opinion of the Investigator, should not be ordinarily screened for PDAC because they do not have risk factors including chronic pancreatitis, family history of PDAC, or genetic cancer syndromes which increase the risk of developing PDAC
- 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
- Contraindications to LINFU®/EUS/ERCP as determined by study investigators:
- Patient with uncorrectable coagulopathy
- Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist
- Unstable medically (cardiopulmonary, neurologic, or cardiovascular status)
- Patients, who in the opinion of the Investigator, are at risk of PDAC because they exhibit any of the following: clinical symptoms of PDAC, imaging abnormalities suggestive of PDAC, genetic syndromes which increase the risk of PDAC, a first degree relative with a history of pancreatic cancer, excessive exposure to dry-cleaning and metalworking chemicals
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- Patients who consume alcohol (greater than 3 drinks/day >1 year or >15g/day for >1 year will be excluded
- Patient with any history of adult-onset diabetes will be excluded
- Patients who are obese (body mass index [BMI] of 30 or more) will be excluded
- Patients who have consumed tobacco in the past for greater than 1 year or current smokers will be excluded.
- Patients with a history of any pancreatic disease, including chronic pancreatitis, or any pancreatic imaging abnormality including intraductal papillary mucinous neoplasm of the pancreas (IPMN)
- Patients with baseline lipase levels that are abnormal
- Pregnant females will be excluded
- Patient that is unable to provide informed consent
- Patient with known allergy to the microbubble contrast agent or secretin
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The LINFU® U.S. Registry for the Detection of Low and High-Grade Atypia and Early, Asymptomatic Pancreatic Ductal Adenocarcinoma (PDAC) in the General Population Without Risk Factors
Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions.. In this study, LINFU® will be evaluated in the general population with no risk factors and who exhibit no signs or symptoms of disease, This study will help determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3).
Read the detailed description
Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) to increase the 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. A contrast agent 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. A neural network-based computer-assisted system may be used to enhance the analysis of specimens.
In this registry, LINFU® will be studied in patients with no risk factors and who exhibit no signs or symptoms of disease. In this registry, a standardized Case Report Form will be completed for every subject enrolled. Information obtained at baseline will include patient history, clinical and demographic information. The results of all diagnostic tests, surgeries, and biopsies performed after the LINFU® technique for a period of 5 years will be recorded and maintained as clinical registry data. This includes testing and procedures received since enrollment including endoscopic ultrasound-fine-needle aspiration (EUS- FNA),magnetic resonance imaging / magnetic resonance cholangiopancreatography (MRI/MRCP), endoscopic retrograde cholangiopancreatography (ERCP), computed tomography (CT), contrast-enhanced ultrasound (CEUS), treatments performed, pathology results, and pancreatic disease history since enrollment.
The registry case report form is the primary data collection instrument for the registry. All data requested on the form must be recorded and these forms will be monitored carefully by the sponsor to ensure they are completely filled out properly.
- Being tested
- LINFU®
- 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
Patients will undergo low intensity non-focused ultrasound excitation of the pancreas for a total of 15 minutes using a GE LOGIQ10 or other FDA approved, FDA cleared or FDA exempt ultrasound insonation. A contrast agent will be administered IV during the ultrasound insonation and the patient will also receive a dose of secretin. The pancreatic juice will then be collected for a total of 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have no risk factors for PDAC | In this study, LINFU® will be evaluated to help identify pancreatic intraepithelial neoplasia-2 (PanIn-2), pancreatic intraepithelial neoplasia-3 (PanIn-3), and early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) in patients with no risk factors and who do not display signs or symptoms of pancreatic disease. Receives: Diagnostic Test: LINFU® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU®
The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions (PanIn-2, PanIn-3) identified with LINFU® by analysis of pancreatic fluid will be recorded.
Measured: 5 years
The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be determined long term
Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be monitored long- term (5 years) by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS to assess whether these tumors increase in size (measured in mm) and to determine how many require medical or surgical intervention.
Measured: 5 years
Secondary outcomes (1)
Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® that require medical or surgical intervention
Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be monitored long- term (5 years) by standard imaging studies (EUS- FNA, MRI/MRCP, ERCP, CT and CEUS) to assess whether these tumors increase and to determine how many require medical or surgical intervention.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Sep 2034 (estimated)
- Study completion15 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Adenocyte, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Haber, MD FRCP, Principal investigator, Manhattan Endoscopy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276803
- Sponsor's protocol ID
- Adenocyte 104
- Status last verified
- May 2024
- First submitted
- 18 Feb 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LINFU® U.S. Registry for the Detection of Low and High-Grade Atypia and Early, Asymptomatic Pancreatic Ductal Adenocarcinoma (PDAC) in the General Population Without Risk Factors
- ClinicalTrials.gov ID
- NCT06276803
- Acronym / sponsor ID
- Adenocyte 104
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Adenocyte, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Sep 2034 (estimated)
- Study completion
- 15 Dec 2034 (estimated)
- First posted
- 26 Feb 2024 (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.
Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions.. In this study, LINFU® will be evaluated in the general population with no risk factors and who exhibit no signs or symptoms of disease, This study will help determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3).
Detailed description
Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) to increase the 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. A contrast agent 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. A neural network-based computer-assisted system may be used to enhance the analysis of specimens.
In this registry, LINFU® will be studied in patients with no risk factors and who exhibit no signs or symptoms of disease. In this registry, a standardized Case Report Form will be completed for every subject enrolled. Information obtained at baseline will include patient history, clinical and demographic information. The results of all diagnostic tests, surgeries, and biopsies performed after the LINFU® technique for a period of 5 years will be recorded and maintained as clinical registry data. This includes testing and procedures received since enrollment including endoscopic ultrasound-fine-needle aspiration (EUS- FNA),magnetic resonance imaging / magnetic resonance cholangiopancreatography (MRI/MRCP), endoscopic retrograde cholangiopancreatography (ERCP), computed tomography (CT), contrast-enhanced ultrasound (CEUS), treatments performed, pathology results, and pancreatic disease history since enrollment.
The registry case report form is the primary data collection instrument for the registry. All data requested on the form must be recorded and these forms will be monitored carefully by the sponsor to ensure they are completely filled out properly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have no risk factors for PDAC | – | Diagnostic Test: LINFU®In this study, LINFU® will be evaluated to help identify pancreatic intraepithelial neoplasia-2 (PanIn-2), pancreatic intraepithelial neoplasia-3 (PanIn-3), and early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) in patients with no risk factors and who do not display signs or symptoms of pancreatic disease. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who do not exhibit any symptoms of PDAC, do not have an abnormal imaging study suggestive of PDAC and who do not have risk factors which increase the risk of developing PDAC.
Key inclusion criteria (5 listed)
- Both males and females will be enrolled and must be at least 18 years of age and under age of 90
- Patients, who in the opinion of the Investigator, do not exhibit any symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc.
- Patients, who in the opinion of the Investigator, do not have an abnormal imaging study suggestive of PDAC
- Patients, who in the opinion of the Investigator, should not be ordinarily screened for PDAC because they do not have risk factors including chronic pancreatitis, family history of PDAC, or genetic cancer syndromes which increase the risk of developing PDAC
- Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
Key exclusion criteria (15 listed)
- Patient under the age of 18 and over the age 90
- Contraindications to LINFU®/EUS/ERCP as determined by study investigators:
- Patients, who in the opinion of the Investigator, are at risk of PDAC because they exhibit any of the following: clinical symptoms of PDAC, imaging abnormalities suggestive of PDAC, genetic syndromes which increase the risk of PDAC, a first degree relative with a history of pancreatic cancer, excessive exposure to dry-cleaning and metalworking chemicals
- Patients who consume alcohol (greater than 3 drinks/day >1 year or >15g/day for >1 year will be excluded
- Patient with any history of adult-onset diabetes 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®Patients will undergo low intensity non-focused ultrasound excitation of the pancreas for a total of 15 minutes using a GE LOGIQ10 or other FDA approved, FDA cleared or FDA exempt ultrasound insonation. A contrast agent will be administered IV during the ultrasound insonation and the patient will also receive a dose of secretin. The pancreatic juice will then be collected for a total of 15 minutes. | Diagnostic test | Patients who have no risk factors for PDAC |
Primary outcome
The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU®
Time frame: 5 years
The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions (PanIn-2, PanIn-3) identified with LINFU® by analysis of pancreatic fluid will be recorded.
The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be determined long term
Time frame: 5 years
Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be monitored long- term (5 years) by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS to assess whether these tumors increase in size (measured in mm) and to determine how many require medical or surgical intervention.
1 secondary outcome
Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® that require medical or surgical intervention
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
Gregory Haber, MD FRCP principal investigator
Manhattan Endoscopy Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Adenocyte, LLC.
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 5 inclusion and 15 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: opening soon, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Lazarus (9142632030, slazarus@adenocyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® (time frame: 5 years). The study lists 2 primary outcomes in all. 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 31 Jul 2024.