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

500 Participants Needed

Trial Summary

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 data supports the effectiveness of the LINFU™ Technique treatment for early detection of pancreatic cancer?

The research highlights the importance of advanced diagnostic techniques like CT scans, MRI, and PET imaging in improving the early detection and diagnosis of pancreatic cancer, which could be relevant to the LINFU™ Technique if it incorporates similar methods. ^{1 2 3 4 5}

Is the LINFU™ Technique safe for humans?

The LINFU™ Technique, which involves endoscopic ultrasound-guided procedures, has been studied for safety in humans. Research shows that the risk of complications is generally low, but caution is advised for patients with certain conditions like liver cirrhosis or hypervascular tumors. Overall, it is considered a safe approach for diagnosing pancreatic lesions. ^{6 7 8 9 10}

How does the LINFU™ Technique for early detection of pancreatic cancer differ from other treatments?

The LINFU™ Technique is unique because it focuses on early detection of pancreatic cancer, which is crucial since this cancer is often diagnosed late when it's harder to treat. Unlike other methods that primarily focus on treatment after diagnosis, this technique aims to identify cancer at a stage where it might be more effectively managed or cured. ^{1 3 4 11 12}

What is the purpose of this trial?

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).

Research Team

Kenneth Meredith

Principal Investigator

Sarasota Memorial Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Preoperative staging and evaluation of resectability in pancreatic ductal adenocarcinoma. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[Developing a hospital-based high risk scoring model and screening strategy for pancreatic cancer]. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

[Diagnostic evaluation of pancreatic carcinoma prompting treatment decisions]. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Advances in the early detection, diagnosis, and staging of pancreatic cancer. [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Diagnosis of carcinoma of the pancreas. [2016]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events of Different Endoscopic Ultrasound-Guided Tissue Acquisition Methods: A Single-Center Retrospective Analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Diagnosing Pancreatic Adenocarcinoma With Contrast-Enhanced Ultrasonography: A Literature Review of Research in Europe and Asia. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Complication incidence of EUS-guided pancreas biopsy: A systematic review and meta-analysis of 11 thousand population from 78 cohort studies. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Diagnosis and Detection of Pancreatic Cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Influence of the safety and diagnostic accuracy of preoperative endoscopic ultrasound-guided fine-needle aspiration for resectable pancreatic cancer on clinical performance. [2021]

11. China pubmed.ncbi.nlm.nih.gov

Imaging of pancreatic cancer: An overview. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Staging of pancreatic adenocarcinoma by imaging studies. [2022]