NCT06276803Not yet recruiting
The LINFU® U.S. Registry for the in the General Population Without Risk Factors
The LINFU® U.S. Registry for the Detection of Low and High-Grade Atypia and Early, Asymptomatic Pancreatic Ductal Adenocarcinoma (PDAC) in the General Population Without Risk Factors
Source: ClinicalTrials.gov · Last updated 31 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.. 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 determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 18 Feb 2024
- Start date
- Sept 2024
- Primary completion date
- Sept 2034
- Lead sponsor
- Adenocyte, LLC
- Diseases
- Pancreatic cancer
- NCT number
- NCT06276803
What you commit to
- Study type: Observational
- Planned participants: 500
- From Sept 2024 to the primary completion date, Sept 2034
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients, who in the opinion of the Investigator, are at risk of PDAC because they exhibit any of the following: clinical symptoms of PDAC, imaging abnormalities suggestive of PDAC, genetic syndromes which increase the risk of PDAC, a first degree relative with a history of pancreatic cancer, excessive exposure to dry-cleaning and metalworking chemicals
- Patient with any history of adult-onset diabetes will be excluded
- Patients with a history of any pancreatic disease, including chronic pancreatitis, or any pancreatic imaging abnormality including intraductal papillary mucinous neoplasm of the pancreas (IPMN)
- Patient with known allergy to the microbubble contrast agent or secretin
Age
- Patient under the age of 18 and over the age 90
Other
- 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 who consume alcohol (greater than 3 drinks/day \>1 year or \>15g/day for \>1 year will be excluded
- Patients who are obese (body mass index \[BMI\] of 30 or more) will be excluded
- Patients who have consumed tobacco in the past for greater than 1 year or current smokers will be excluded.
- Patients with baseline lipase levels that are abnormal
- Pregnant females will be excluded
- Patient that is unable to provide informed consent
Who the study is looking for
- 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, do not exhibit any symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc.
- Patients, who in the opinion of the Investigator, do not have an abnormal imaging study suggestive of PDAC
- Patients, who in the opinion of the Investigator, should not be ordinarily screened for PDAC because they do not have risk factors including chronic pancreatitis, family history of PDAC, or genetic cancer syndromes which increase the risk of developing PDAC
- Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.