LINFU™ Technique for Early Detection of Pancreatic Cancer

Overseen By Stephanie Lazarus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Adenocyte, LLC

Disqualifiers: Coagulopathy, Cardiopulmonary issues, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new technique called LINFU™, which uses ultrasound to detect early signs of pancreatic cancer. The focus is on identifying cancer before symptoms appear, especially in individuals with risk factors such as smoking, diabetes, or a family history of pancreatic cancer. Participants should have known risk factors or symptoms and be undergoing other imaging tests.

As a Phase 2 trial, this research measures the technique's effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage advancements in cancer detection.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigators.

What prior data suggests that the LINFU™ Technique is safe for early detection of pancreatic cancer?

Research has shown that the LINFU™ Technique is generally safe for patients. This method uses gentle ultrasound waves to collect fluid from the pancreas, which is then checked for early signs of pancreatic cancer. Studies indicate a low risk of complications. However, individuals with certain conditions, such as liver cirrhosis, may require extra care. Overall, the procedure is well-tolerated with few reported side effects, making it a promising option for early cancer detection in at-risk individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LINFU™ Technique because it offers a potentially groundbreaking method for early detection of pancreatic cancer, which is notoriously difficult to diagnose in its initial stages. Unlike existing techniques that rely heavily on imaging tests like CT scans or MRIs, LINFU™ focuses on identifying specific risk factors, such as smoking, diabetes, or genetic predispositions, to screen individuals more precisely. This approach could lead to earlier intervention and potentially improve survival rates by catching the disease before it progresses too far. By honing in on these risk factors, LINFU™ aims to streamline the screening process, reducing the reliance on invasive diagnostic procedures.

What evidence suggests that the LINFU™ Technique is effective for early detection of pancreatic cancer?

Research has shown that the LINFU™ technique, which participants in this trial will undergo, might help identify early signs of pancreatic cancer. This method uses gentle ultrasound waves and examines pancreatic fluid to detect cancer indicators. Early results suggest it could identify pancreatic cancer and its early warning signs in high-risk individuals, even before symptoms appear. A computer system may enhance the accuracy of this detection. While researchers continue to gather data on its effectiveness, combining ultrasound with advanced analysis appears promising for early detection of pancreatic cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Kenneth Meredith

Principal Investigator

Sarasota Memorial Hospital

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 to 90 who may have pancreatic cancer due to symptoms, imaging results, or are undergoing a specific diagnostic procedure (EUS/FNA). They must be able to consent. It's not suitable for those with certain conditions that aren't specified here.

Inclusion Criteria

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

I am at high risk for pancreatic cancer but do not have symptoms.

I am at high risk for pancreatic cancer due to my history or symptoms.

Exclusion Criteria

I do not have any health conditions that prevent me from undergoing certain medical procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

LINFU® Procedure

Participants undergo the LINFU® procedure involving low intensity non-focused ultrasound excitation of the pancreas and analysis of pancreatic fluid

1 day

1 visit (in-person)

Follow-up

Participants are monitored for the detection of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions

5 years

Regular visits (in-person and virtual) for diagnostic tests and monitoring

What Are the Treatments Tested in This Trial?

Interventions

• LINFU™ Technique

Trial Overview The LINFU™ technique is being tested as a noninvasive way to collect cells from the pancreas using ultrasound. This could help detect early-stage pancreatic cancer in people at risk due to factors like smoking or family history.

How Is the Trial Designed?

Group I: Patients at increased risk for developing pancreatic cancer Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Adenocyte, LLC

Lead Sponsor

Trials

6

Recruited

3,500+

Published Research Related to This Trial

In a study of 192 patients undergoing endoscopic ultrasound-guided tissue acquisition (EUS-TA) for pancreatic lesions, hypervascular tumors and liver cirrhosis were identified as significant risk factors for adverse events, with odds ratios of 4.96 and 5.3, respectively.

The use of Franseen-tip needles did not increase the risk of adverse events compared to conventional FNA or FNB needles, suggesting that these newer needles are as safe as traditional options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events of Different Endoscopic Ultrasound-Guided Tissue Acquisition Methods: A Single-Center Retrospective Analysis. Lin, YC., Yen, HH., Huang, SP., et al.[2022]

Computed tomography (CT) is the most effective imaging method for diagnosing pancreatic adenocarcinoma, with a high sensitivity of 89%-97% and a strong positive predictive value for determining unresectability (89%-100%).

While CT is excellent for diagnosis, its ability to predict resectability is lower (45%-79%) due to a focus on specificity, and it has limited sensitivity for detecting small metastases; endoscopic ultrasound is superior for local staging but not for distant metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staging of pancreatic adenocarcinoma by imaging studies. Wong, JC., Lu, DS.[2022]

Citations

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

The LINFU® U.S. Registry for the in the General Population ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06276764

NCT06276764 | The LINFU® U.S. Registry in Patients With ... 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 ...

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

LINFU™ Technique for Early Detection of Pancreatic Cancer What data supports the effectiveness of the LINFU™ Technique treatment for early detection of pancreatic cancer? The research highlights the importance of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1044579X25000379

Biomarkers, omics and artificial intelligence for early ... In effect, NOD is an early warning sign of the presence of PDAC, and individuals with NOD over 50 years have a 6–8-fold higher risk of PDAC than the general ...

5. 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.

6. 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 ... 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 ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04793633/evaluating-linfutm-a-noninvasive-method-for-collecting-pancreatic-cells-for-the-early-detection-of-pancreatic-cancer

Evaluating LINFU™: A Noninvasive Method for Collecting ... LINFU® consists of analysis of pancreatic fluid collected with the help of low intensity non-focused ultrasound excitation of the pancreas. A ...