NCT06435286RecruitingPhase 2
Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening: A Clinical Study in Brazil and the United States
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) interpretation by experts but not the novice and in the surveillance arm (100% vs. 19%, p \<0.05). In the screening arm, diagnostic yield (neoplastic biopsies/total biopsies) increased 3.6 times (8 to 29%); 16% of patients were correctly spared any biopsy, and 18% had a change in clinical plan. In a pilot study in Brazil, the investigators tested a software-assisted mHRME with deep-learning software algorithms to aid in the detection of neoplastic images and determine the performance, efficiency, and impact of the AI-mHRME when to Lugol's chromoendoscopy (LCE) alone and when using AI-mHRME with LCE. In this clinical trial, the investigators will build on the Brazil pilot trial data to optimize an artificial intelligence (AI) mHRME and evaluate its clinical impact and implementation potential in ethnically and socioeconomically diverse populations in the US and Brazil.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 24 May 2024
- Start date
- 17 Feb 2025
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06435286
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 17 Feb 2025 to the primary completion date, 1 Mar 2027
- 4 sites in 2 countries
- 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.
Prior treatment
- Allergy or prior reaction to the fluorescent contrast agent proflavine hemisulfate.
Other illness
- 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.
Lab values
- Prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0,
Other
- Patients who are unable to give informed consent.
- Patient unable to undergo routine endoscopy with biopsy:
- Women who are pregnant or breast feeding,
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Cancer de Barretos - Fundacao Pio XII Coordinator of this site? Confirm its status | Barretos | Brazil | Recruiting |
| Instituto do Câncer do Estado de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Baylor St. Luke's Medical Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Ben Taub Hospital (Harris Health Systems) Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.