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NCT06435286 · ClinicalTrials.gov registry record · Phase 2
Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
A Phase 2 study of Suspected or Known Squamous Cell Neoplasia and Prior History of Squamous Cell Dysplasia and /or Neoplasia, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 4
- Study locations
NCT06435286: Recruiting Phase 2 study of Suspected or Known Squamous Cell Neoplasia and Prior History of Squamous Cell Dysplasia and /or Neoplasia, sponsored by Baylor College of Medicine.
NCT06435286 is a Phase 2 study of Suspected or Known Squamous Cell Neoplasia and Prior History of Squamous Cell Dysplasia and /or Neoplasia that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06435286, a Phase 2 study of Suspected or Known Squamous Cell Neoplasia and Prior History of Squamous Cell Dysplasia and /or Neoplasia, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
Change in clinical plan ('biopsy vs. no biopsy vs. treat') following AI-mHRME.
Conditions Studied
Interventions
- DRUG Proflavine Hemisulfate
- DEVICE Artificial Intelligence Mobile High-Resolution Microendoscope
Study Locations (4)
Texas
- Baylor St. Luke's Medical Center - Houston
- Ben Taub Hospital (Harris Health Systems) - Houston
São Paulo
- Hospital de Cancer de Barretos - Fundacao Pio XII - Barretos
- Instituto do Câncer do Estado de São Paulo - São Paulo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-02-17 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
What NCT06435286 shows while recruiting
NCT06435286 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 2 conditions, with Suspected or Known Squamous Cell Neoplasia appearing as the primary indexed condition, and to 2 interventions - of which Proflavine Hemisulfate is the first listed.
NCT06435286 reports a single indexed study location in Texas, São Paulo.
Frequently Asked Questions
What is clinical trial NCT06435286 about?
NCT06435286 is a clinical study titled "Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States". 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) int...
What is the current status of trial NCT06435286?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2025-02-17. Estimated completion is 2027-03-01.
What conditions does trial NCT06435286 study?
This clinical trial studies the following conditions: Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia.
What interventions are being tested in trial NCT06435286?
The interventions under investigation include: Proflavine Hemisulfate (DRUG), Artificial Intelligence Mobile High-Resolution Microendoscope (DEVICE).
Who is sponsoring clinical trial NCT06435286?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06435286 being conducted?
This trial has 4 study locations across Texas, São Paulo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06435286's enrollment target sits among peer trials
200 304th of 2000 higher than 1,653 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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