AI-Powered pocket microscope could revolutionize esophageal cancer detection
NCT ID NCT06435286
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a portable microscope with artificial intelligence to help doctors spot early signs of esophageal cancer during a routine scope exam. Researchers will enroll 200 adults in Brazil and the United States who are already scheduled for screening. The goal is to see if the AI tool can reduce unnecessary biopsies and improve detection accuracy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment, including patients with a known history of head/neck squamous cell cancer; heavy smoking and alcohol, other dietary or geographic risk factors or prior dysplasia * Patients \>18 years old. * Patients of any sex or gender. * Patients who are willing and able to give informed consent. Exclusion Criteria: * Allergy or prior reaction to the fluorescent contrast agent proflavine hemisulfate. * Patients who are unable to give informed consent. * Known advanced squamous cell carcinoma of the distal esophagus or dysplastic/suspected malignant esophageal lesion greater than or equal to 2 cm in size not amenable to endoscopic therapy. * Patient unable to undergo routine endoscopy with biopsy: * Women who are pregnant or breast feeding, * Prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0, * Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor St. Luke's Medical Center
RECRUITINGHouston, Texas, 77030, United States
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Ben Taub Hospital (Harris Health Systems)
RECRUITINGHouston, Texas, 77030, United States
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Hospital de Cancer de Barretos - Fundacao Pio XII
RECRUITINGBarretos, São Paulo, 14784-400, Brazil
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Instituto do Câncer do Estado de São Paulo
RECRUITINGSão Paulo, São Paulo, 01246-000, Brazil