Gastrointestinal NeoplasmNCT07228689
AI for Onsite Cytology Evaluation in Endoscopic Ultrasound
An observational study of Gastrointestinal Neoplasm and Mass Lesion, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
The aim of this study is to determine if the widely available artificial intelligence platform ChatGPT can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasm, Mass Lesion
- What is being tested?
- EUS-guided fine needle biopsy
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to Dec 2026
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or greater, undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract.
Who may be able to join
- Age 18 years old or greater
- Patients undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract
Who cannot join
- Age less than 18 years
- Patients not undergoing sampling of solid mass lesions at EUS
- Patients with cystic lesions in the gastrointestinal tract
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Health Digestive Health Institute
Orlando, Florida, 32806
About this study
Official title: Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound
The aim of this study is to determine if the widely available artificial intelligence platform ChatGPT can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold standard.
Read the detailed description
The diagnostic accuracy of EUS-guided fine needle biopsy of lesions in the gastrointestinal tract is dependent on the availability of a cytopathologist to render a rapid on-site evaluation (ROSE), with studies showing that the presence of an on-site cytopathologist improves the diagnostic yield, decreases the number of inadequate or unsatisfactory samples, and limits the number of passes required to establish a diagnosis. However, the availability of ROSE is variable across centers and regions, with the availability of onsite cytopathology services limited to a handful of tertiary referral centers in the United States.
ChatGPT is a universally available, generative artificial intelligence program developed by OpenAI. The aim of this study is to determine if this AI platform can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold standard.
- Conditions
- Gastrointestinal Neoplasm, Mass Lesion
- Being tested
- EUS-guided fine needle biopsy
- Keywords
- endoscopic ultrasound, solid mass lesion, artificial intelligence, fine needle biopsy
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided fine needle biopsyDiagnostic test
EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract
| Study group | Role | What they receive |
|---|---|---|
| Interpretation of cytology specimen by cytopathologist onsite | The interpretation of the cytology specimens will be made onsite by the cytopathologist Receives: Diagnostic Test: EUS-guided fine needle biopsy | |
| Interpretation of cytology specimen by artificial intelligence | The interpretation of the cytology specimens will be made onsite by the AI program Receives: Diagnostic Test: EUS-guided fine needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic adequacy at rapid onsite evaluation
The ability of the AI systems to interpret specimen adequacy on cytology images
Measured: 1 day
Secondary outcomes (1)
Diagnostic accuracy at rapid onsite evaluation
The ability of the AI systems to interpret and diagnose cytology images
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start17 Nov 2025
- Primary completion6 Apr 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmStudies 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
- 136 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Young Bang, MD MPH, Principal investigator, Orlando Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228689
- Sponsor's protocol ID
- 2343877
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound
- ClinicalTrials.gov ID
- NCT07228689
- Acronym / sponsor ID
- 2343877
- Conditions
- Gastrointestinal Neoplasm, Mass Lesion
- Keywords
- endoscopic ultrasound, solid mass lesion, artificial intelligence, fine needle biopsy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Nov 2025 (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 aim of this study is to determine if the widely available artificial intelligence platform ChatGPT can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold standard.
Detailed description
The diagnostic accuracy of EUS-guided fine needle biopsy of lesions in the gastrointestinal tract is dependent on the availability of a cytopathologist to render a rapid on-site evaluation (ROSE), with studies showing that the presence of an on-site cytopathologist improves the diagnostic yield, decreases the number of inadequate or unsatisfactory samples, and limits the number of passes required to establish a diagnosis. However, the availability of ROSE is variable across centers and regions, with the availability of onsite cytopathology services limited to a handful of tertiary referral centers in the United States.
ChatGPT is a universally available, generative artificial intelligence program developed by OpenAI. The aim of this study is to determine if this AI platform can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpretation of cytology specimen by cytopathologist onsite | – | Diagnostic Test: EUS-guided fine needle biopsyThe interpretation of the cytology specimens will be made onsite by the cytopathologist |
| Interpretation of cytology specimen by artificial intelligence | – | Diagnostic Test: EUS-guided fine needle biopsyThe interpretation of the cytology specimens will be made onsite by the AI program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or greater, undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract.
Key inclusion criteria (2 listed)
- Age 18 years old or greater
- Patients undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract
Key exclusion criteria (3 listed)
- Age less than 18 years
- Patients not undergoing sampling of solid mass lesions at EUS
- Patients with cystic lesions in the gastrointestinal tract
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 |
|---|---|---|
| EUS-guided fine needle biopsyEUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract | Diagnostic test | Interpretation of cytology specimen by artificial intelligence, Interpretation of cytology specimen by cytopathologist onsite |
Primary outcome
Diagnostic adequacy at rapid onsite evaluation
Time frame: 1 day
The ability of the AI systems to interpret specimen adequacy on cytology images
1 secondary outcome
Diagnostic accuracy at rapid onsite evaluation
Time frame: 7 days
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 30 Jun 2026.
Related trials for Gastrointestinal Neoplasm
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
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. This study is not recruiting at the moment.
Ji Young Bang, MD MPH principal investigator
Orlando Health
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 Gastrointestinal Neoplasm and Mass Lesion, 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 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic adequacy at rapid onsite evaluation (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 30 Jun 2026.