Pancreatic CancerNCT06564571
Artificial Intelligence in Endoscopic Ultrasound
An observational study of Pancreatic Cancer and Pancreas Disease, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer, Pancreas Disease, Pancreatic Cyst
- What is being tested?
- Patients undergoing endoscopic ultrasound procedures
- Type of treatment
- Medical device
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2024to Dec 2027
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient 18 years or over undergoing endoscopic ultrasound examination
Who may be able to join
- Age ≥ 18 years
- Any patient undergoing endoscopic ultrasound examination
Who cannot join
- Age < 18 years
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, 1 recruiting
- Recruiting
Orlando Health
Orlando, Florida, 32806
Shyam Varadarajulu, MD, 321-841-2431, shyam.varadarajulu@orlandohealth.com
Barbara Broome, 321-841-4356, barbara.broome@orlandohealth.com
About this study
The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures.
Read the detailed description
Endoscopic Ultrasound (EUS) is an equipment where an ultrasound transducer is attached to the tip of the endoscope. When advanced to the stomach the organs outside such as the pancreas and liver can be visualized in great detail. This enables diagnosis of conditions such as pancreatic cancer. However, an endoscopist must undergo training to accurately interpret these ultrasound images.
The investigators are in the process of developing an artificial intelligence system that could potentially interpret EUS images. The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures. Such correlation if established will lead to possible development of an artificial intelligence platform that can diagnose pancreatic diseases. Such development will potentially minimize human error and decrease learning curve to gain proficiency in EUS.
- Conditions
- Pancreatic Cancer, Pancreas Disease, Pancreatic Cyst
- Being tested
- Patients undergoing endoscopic ultrasound procedures
- Keywords
- pancreatic disease, pancreatic cancer, pancreatic cyst, artificial intelligence
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases, Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergoing endoscopic ultrasound proceduresDevice
Patients will undergo endoscopic ultrasound procedures as planned. Abnormalities in the pancreas identified by the endoscopist during the endoscopic ultrasound examination will be correlated against those detected by the AI platform.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing endoscopic ultrasound procedures | Patients will undergo endoscopic ultrasound procedures as planned. Abnormalities in the pancreas identified by the endoscopist during the endoscopic ultrasound examination will be correlated against those detected by the AI platform. Receives: Device: Patients undergoing endoscopic ultrasound procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of detection pancreatic abnormalities by AI
Ability of AI to detect pancreatic abnormalities as identified by an endoscopist during EUS examination of the pancreas.
Measured: 1 day
Secondary outcomes (2)
Rate of detection pancreatic solid mass lesions by AI
Ability of AI to detect pancreatic solid mass lesions as identified by an endoscopist during EUS examination of the pancreas.
Measured: 1 day
Rate of detection pancreatic cystic lesions by AI
Ability of AI to detect pancreatic cystic lesions as identified by an endoscopist during EUS examination of the pancreas.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start19 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyam Varadarajulu, MD, Principal investigator, Orlando Health, Digestive Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564571
- Sponsor's protocol ID
- 24.015.01
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in Endoscopic Ultrasound
- ClinicalTrials.gov ID
- NCT06564571
- Acronym / sponsor ID
- 24.015.01
- Conditions
- Pancreatic Cancer, Pancreas Disease, Pancreatic Cyst
- Keywords
- pancreatic disease, pancreatic cancer, pancreatic cyst, artificial intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Aug 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.
The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures.
Detailed description
Endoscopic Ultrasound (EUS) is an equipment where an ultrasound transducer is attached to the tip of the endoscope. When advanced to the stomach the organs outside such as the pancreas and liver can be visualized in great detail. This enables diagnosis of conditions such as pancreatic cancer. However, an endoscopist must undergo training to accurately interpret these ultrasound images.
The investigators are in the process of developing an artificial intelligence system that could potentially interpret EUS images. The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures. Such correlation if established will lead to possible development of an artificial intelligence platform that can diagnose pancreatic diseases. Such development will potentially minimize human error and decrease learning curve to gain proficiency in EUS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing endoscopic ultrasound procedures | – | Device: Patients undergoing endoscopic ultrasound proceduresPatients will undergo endoscopic ultrasound procedures as planned. Abnormalities in the pancreas identified by the endoscopist during the endoscopic ultrasound examination will be correlated against those detected by the AI platform. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient 18 years or over undergoing endoscopic ultrasound examination
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Any patient undergoing endoscopic ultrasound examination
Key exclusion criteria (1 listed)
- Age < 18 years
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 |
|---|---|---|
| Patients undergoing endoscopic ultrasound proceduresPatients will undergo endoscopic ultrasound procedures as planned. Abnormalities in the pancreas identified by the endoscopist during the endoscopic ultrasound examination will be correlated against those detected by the AI platform. | Device | Patients undergoing endoscopic ultrasound procedures |
Primary outcome
Rate of detection pancreatic abnormalities by AI
Time frame: 1 day
Ability of AI to detect pancreatic abnormalities as identified by an endoscopist during EUS examination of the pancreas.
2 secondary outcomes
Rate of detection pancreatic solid mass lesions by AI
Time frame: 1 day
Rate of detection pancreatic cystic lesions by AI
Time frame: 1 day
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 31 May 2025.
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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.
Shyam Varadarajulu, MD principal investigator
Orlando Health, Digestive Health Institute
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 Pancreatic Cancer and Pancreas Disease, run by Orlando Health, Inc. 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 31 May 2025. 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?
Contact Shyam Varadarajulu, MD (321-841-2431, shyam.varadarajulu@orlandohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of detection pancreatic abnormalities by AI (time frame: 1 day). 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 31 May 2025.