LINFU™ Technique for Pancreatic Cancer

Overseen By Stephanie Lazarus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Adenocyte, LLC

Disqualifiers: Pregnancy, Allergy to Lumason, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to detect early signs of pancreatic cancer using ultrasound technology. It involves a technique called LINFU™, which examines pancreatic fluid for possible precancerous changes. This approach targets individuals at higher risk of developing pancreatic cancer who are already undergoing tests like an MRI or an EUS (a type of ultrasound exam). The trial may suit those currently undergoing these screenings and facing a significantly increased risk of pancreatic cancer. As an unphased trial, it offers patients a unique opportunity to contribute to groundbreaking research in early cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that the LINFU™ Technique is safe for detecting pancreatic precancer and cancer?

Research has shown that the LINFU™ technique is safe for detecting early signs of pancreatic cancer. In past studies, LINFU™ used ultrasound to examine fluid from the pancreas and was generally well-tolerated by patients, with no major safety issues reported.

The process creates bubbles with a substance called Lumason and uses a medication called secretin to gather more cells from the pancreas. Both have been safely used in other medical procedures. Overall, the LINFU™ technique appears promising without causing significant side effects or harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LINFU™ because it offers a novel approach to diagnosing pancreatic conditions. Unlike standard methods like endoscopic ultrasound or CT scans, LINFU™ uses low-intensity, non-focused ultrasound to stimulate the pancreas and collect fluid samples more effectively. By employing Lumason to create bubbles, LINFU™ potentially increases the yield of pancreatic cells in the fluid, enhancing the sensitivity of cytology tests. This innovative technique could lead to earlier and more accurate detection of pancreatic issues, a significant advancement over current diagnostic options.

What evidence suggests that the LINFU™ technique is effective for detecting pancreatic precancer and cancer?

Research has shown that the LINFU™ technique, which participants in this trial will experience, might help detect pancreatic cancer early. This method uses ultrasound to collect fluid from the pancreas for analysis. By gently stimulating the pancreas with low-intensity ultrasound and using a special agent to create bubbles, LINFU™ aims to gather more cells for testing. Early results suggest this approach could improve the detection of early-stage pancreatic cancer and ductal adenocarcinoma. The technique might also employ a computer system to enhance the analysis. Although still under testing, this method shows promise for earlier detection of pancreatic cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Scott Corbett, MD, FASGE

Principal Investigator

Suncoast Endoscopy of Sarasota (a division of Florida Digestive Health Specialists)

Are You a Good Fit for This Trial?

Inclusion Criteria

You have a high chance of getting pancreatic cancer.

Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

You will need to undergo an EUS or MRI scan as part of your screening.

Exclusion Criteria

Pregnant females will be excluded.

Patient under the age of 18 and over the age 90

The study investigators have determined that you cannot undergo EUS (endoscopic ultrasound) due to certain reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

LINFU™ Procedure

Participants undergo the LINFU™ Technique, which involves ultrasound excitation of the pancreas, administration of Lumason and secretin, and collection of pancreatic fluid

1 day

1 visit (in-person)

Follow-up

Participants are monitored for symptoms of pancreatitis and undergo blood tests to measure lipase levels

4 weeks

2 follow-up calls, 1 visit if symptoms develop

What Are the Treatments Tested in This Trial?

Interventions

• LINFU™

How Is the Trial Designed?

Group I: The LINFU™ test Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Adenocyte, LLC

Lead Sponsor

Trials

6

Recruited

3,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06276803

The LINFU® U.S. Registry for the in the General Population ... LINFU® consists of analysis of pancreatic fluid collected with the help of low intensity non-focused ultrasound excitation of the pancreas. A contrast agent ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-05912

Evaluating LINFU™: A Noninvasive Method for Collecting ... The purpose of this research study is to develop a method to detect pancreatic cancer (ductal adenocarcinoma) using ultrasound technology.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05161013?tab=table

NCT05161013 | A Proof-of-Concept Study Evaluating LINFU The purpose of this research study is to study a method to detect pancreatic precancer and cancer (ductal adenocarcinoma) using ultrasound technology in those ...

4. withpower.com withpower.com/trial/phase-adenocarcinoma-3-2021-26f15

LINFU™ Technique for Early Detection of Pancreatic Cancer The test involves ultrasound and an analysis of pancreatic juice. A neural network-based computer-assisted system may be utilized to enhance the analysis.

5. npcf.us npcf.us/clinical-trials/evaluating-linfu-a-noninvasive-method-for-collecting-pancreatic-cells-for-the-early-detection-of-pancreatic-cancer/

Evaluating LINFU™: A Noninvasive Method For Collecting ... The test involves ultrasound and an analysis of pancreatic juice. A neural network-based computer-assisted system may be utilized to enhance the analysis.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06276738

NCT06276738 | The LINFU® U.S. Registry in Patients With ... Patients with pancreatic ductal adenocarcinomas identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9593257/

Diagnostic yield of liquid‐based cytology in serial ... We evaluated the diagnostic efficacy of liquid‐based cytology (LBC) in pancreatic juice cytology for pancreatic cancer.

8. npcf.us npcf.us/clinical-trials/the-linfu-u-s-registry-for-the-detection-of-asymptomatic-pancreatic-ductal-adenocarcinoma/

The LINFU® U.S. Registry For The Detection Of ... The test involves ultrasound and an analysis of pancreatic juice. A neural network-based computer-assisted system may be utilized to enhance the analysis.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10453209/

Diagnostic Ability and Safety of Repeated Pancreatic Juice ... Diagnostic ability and safety of repeated pancreatic juice cytology using an endoscopic nasopancreatic drainage catheter for pancreatic ductal adenocarcinoma.