Pancreatic Ductal AdenocarcinomaNCT04793633
Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer
An observational study of Pancreatic Ductal Adenocarcinoma, run by Adenocyte, LLC at 1 site in United States.
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. The test involves ultrasound and an analysis of pancreatic juice. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- LINFU™ Technique
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2024to 30 Dec 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with risk factors for pancreatic cancer or those with signs and symptoms of pancreatic cancer who are scheduled for EUS± FNA, MRI/MRCP, ERCP, CT or CEUS will be enrolled.
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, are at elevated risk of developing a pancreatic malignancy because they have known risk factors for PDAC or signs or symptoms of PDAC
- High risk asymptomatic patients being screened for PDAC
- Patients with clinical signs or symptoms of PDAC including abnormal imaging and who are scheduled for EUS- FNA, MRI/MRCP, ERCP, or CT will be enrolled
- 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 undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium
Show all 9Show fewer
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Sarasota Memorial HealthCare System
Sarasota, Florida, 34239
About this study
Official title: The LINFU® (A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into Pancreatic Fluid) U.S. Registry for the Detection of PanIn-2, PanIn-3, and Early, Asymptomatic Pancreatic Ductal Adenocarcinoma (PDAC)
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. The test involves ultrasound and an analysis of pancreatic juice. A neural network-based computer-assisted system may be utilized to enhance the analysis. Patients enrolled are being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes).
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 who are at increased risk for developing pancreatic cancer as well as those with 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 including relevant comorbidities and pancreatic disease history, and screening and pathology test results. 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 EUS- FNA, MRI/MRCP, ERCP, CT, 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.
.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- LINFU™ Technique
- Keywords
- Pancreatic Intraepithelial Neoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINFU™ TechniqueCombination product
Non-focused ultrasound excitation of the pancreas with IV Lumason and IV secretin injected during the ultrasound procedure.
| Study group | Role | What they receive |
|---|---|---|
| Patients at increased risk for developing pancreatic cancer | Patients being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes) or have signs or symptoms of disease and are undergoing other imaging diagnostic tests to determine if they have pancreatic cancer Receives: Combination Product: LINFU™ Technique |
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
The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including EUS- FNA, MRI/MRCP, ERCP, CT and CEUS.
Measured: 5 years
Secondary outcomes (2)
The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined.
Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® and not detected with other diagnostic tests 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
Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention.
Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS to assess whether these tumors increase 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 posted11 Mar 2021
- Study start31 Jan 2024
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adenocyte, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth B Meredith, MD, Principal investigator, Sarasota Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793633
- Sponsor's protocol ID
- Adenocyte 110
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2021
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LINFU® (A Noninvasive Method for Increasing Exfoliation of Pancreatic Ductal Cells Into Pancreatic Fluid) U.S. Registry for the Detection of PanIn-2, PanIn-3, and Early, Asymptomatic Pancreatic Ductal Adenocarcinoma (PDAC)
- ClinicalTrials.gov ID
- NCT04793633
- Acronym / sponsor ID
- Adenocyte 110
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Pancreatic Intraepithelial Neoplasia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Adenocyte, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 11 Mar 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.
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. The test involves ultrasound and an analysis of pancreatic juice. A neural network-based computer-assisted system may be utilized to enhance the analysis. Patients enrolled are being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes).
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 who are at increased risk for developing pancreatic cancer as well as those with 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 including relevant comorbidities and pancreatic disease history, and screening and pathology test results. 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 EUS- FNA, MRI/MRCP, ERCP, CT, 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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at increased risk for developing pancreatic cancer | – | Combination Product: LINFU™ TechniquePatients being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes) or have signs or symptoms of disease and are undergoing other imaging diagnostic tests to determine if they have pancreatic cancer |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with risk factors for pancreatic cancer or those with signs and symptoms of pancreatic cancer who are scheduled for EUS± FNA, MRI/MRCP, ERCP, CT or CEUS will be enrolled.
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, are at elevated risk of developing a pancreatic malignancy because they have known risk factors for PDAC or signs or symptoms of PDAC
- High risk asymptomatic patients being screened for PDAC
- Patients with clinical signs or symptoms of PDAC including abnormal imaging and who are scheduled for EUS- FNA, MRI/MRCP, ERCP, or CT will be enrolled
- Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
Key exclusion criteria (9 listed)
- Patient under the age of 18 and over the age 90
- Contraindications to LINFU/EUS/ERCP 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
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™ TechniqueNon-focused ultrasound excitation of the pancreas with IV Lumason and IV secretin injected during the ultrasound procedure. | Combination product | Patients at increased risk for developing pancreatic cancer |
Primary outcome
The number of pancreatic ductal adenocarcinomas and their noninvasive precursor
Time frame: 5 years
The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including EUS- FNA, MRI/MRCP, ERCP, CT and CEUS.
2 secondary outcomes
The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined.
Time frame: 5 years
Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only 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 12 Mar 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.
Kenneth B Meredith, MD principal investigator
Sarasota Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, 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 5 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 12 Mar 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?
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?
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?
The number of pancreatic ductal adenocarcinomas and their noninvasive precursor (time frame: 5 years). 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 12 Mar 2024.