IPMN, PancreaticNCT06276764
The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)
An observational study of IPMN, Pancreatic and Pancreas Cancer, run by Adenocyte, LLC at 1 site in United States.
Trial summary
In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- IPMN, Pancreatic, Pancreas Cancer, Pancreatic Cyst
- What is being tested?
- LINFU®
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 1 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 with a documented history of IPMN by any imaging method.
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 with a documented history of IPMN by any imaging method.
- All patients must undergo contemporaneous imaging (within 90 days before or after the LINFU® procedure) with one or more of the following: EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT
- Patients undergoing EUS-FNA may be enrolled but the FNA must be performed after the LINFU® procedure
- 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® 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 with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure
Show all 11Show fewer
- Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions
- Pregnant females will be excluded
- Patient that is unable to provide informed consent
- Patient with known allergy to the microbubble contrast agent or secretin
- Study Design Overview:
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
Manhattan Endoscopy Center
New York, New York, 10007
About this study
Official title: The LINFU® U.S. Registry for the Detection of Dysplasia and Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)
In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes.
Read the detailed description
Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) that increases the sensitivity of pancreatic juice cytology. LINFU® excitation of circulating microbubbles increases the exfoliation of pancreatic ductal cells. The sensitivity of cytological examination of the pancreatic fluid obtained by LINFU® can also be potentially enhanced by neural network-based computer-assisted analysis.
In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia) which are not identified with current diagnostic tests. In addition, patients identified with PDAC or precursor lesions only with LINFU® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and whether LINFU® results in earlier intervention, treatment and improvement in patient outcomes
- Conditions
- IPMN, Pancreatic, Pancreas Cancer, Pancreatic Cyst
- Being tested
- LINFU®
- Medical subject headings
- Pancreatic Intraductal Neoplasms, Pancreatic Neoplasms, Pancreatic Cyst
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. A contrast agent will be administered IV at five minute intervals. The patient will then receive a dose of secretin and the the patient's pancreatic juice will then be collected for a total of 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a documented history of IPMN | Patients with a documented history of IPMN by any imaging method will undergo the LINFU® procedure. 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 or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods
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, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT
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 over a 5 year period
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, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT 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, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT 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 posted26 Feb 2024
- Study start15 Oct 2024
- Primary completion30 Sep 2034 (estimated)
- Study completion1 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPMN, PancreaticStudies 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
- NCT06276764
- Sponsor's protocol ID
- Adenocyte 103
- Status last verified
- Aug 2026
- First submitted
- 18 Feb 2024
- Last updated
- 6 Aug 2026
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LINFU® U.S. Registry for the Detection of Dysplasia and Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)
- ClinicalTrials.gov ID
- NCT06276764
- Acronym / sponsor ID
- Adenocyte 103
- Conditions
- IPMN, Pancreatic, Pancreas Cancer, Pancreatic Cyst
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Adenocyte, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Sep 2034 (estimated)
- Study completion
- 1 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.
In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes.
Detailed description
Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) that increases the sensitivity of pancreatic juice cytology. LINFU® excitation of circulating microbubbles increases the exfoliation of pancreatic ductal cells. The sensitivity of cytological examination of the pancreatic fluid obtained by LINFU® can also be potentially enhanced by neural network-based computer-assisted analysis.
In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia) which are not identified with current diagnostic tests. In addition, patients identified with PDAC or precursor lesions only with LINFU® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and whether LINFU® results in earlier intervention, treatment and improvement in patient outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a documented history of IPMN | – | Diagnostic Test: LINFU®Patients with a documented history of IPMN by any imaging method will undergo the LINFU® procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a documented history of IPMN by any imaging method.
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 with a documented history of IPMN by any imaging method.
- All patients must undergo contemporaneous imaging (within 90 days before or after the LINFU® procedure) with one or more of the following: EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT
- Patients undergoing EUS-FNA may be enrolled but the FNA must be performed after the LINFU® procedure
- Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
Key exclusion criteria (11 listed)
- Patient under the age of 18 and over the age 90
- Contraindications to LINFU® as determined by study investigators:
- Patients with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure
- Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions
- 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®Patients will undergo low intensity non-focused ultrasound excitation of the pancreas for a total of 15 minutes. A contrast agent will be administered IV at five minute intervals. The patient will then receive a dose of secretin and the the patient's pancreatic juice will then be collected for a total of 15 minutes. | Diagnostic test | Patients with a documented history of IPMN |
Primary outcome
The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods
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, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT
2 secondary outcomes
The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period
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 6 Aug 2026.
- 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
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 IPMN, Pancreatic and Pancreas Cancer, 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 11 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 6 Aug 2026. 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 or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods (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 6 Aug 2026.