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Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 4 sitesv6
  2. Collaborators: 4 to 5v5 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 1, 2025 to Feb 17, 2025 · Site details revised at 4 of 4 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Mar 1, 2025 to Feb 17, 2025
    • Site details revised at 4 of 4 sites
  4. Start date: Nov 1, 2024 to Mar 1, 2025 Primary and study completion dates: Nov 1, 2026 to Mar 1, 2027v3 Show 1 more changeShow less
    • Primary and study completion dates: Nov 1, 2026 to Mar 1, 2027
  5. Start date: Aug 1, 2024 to Nov 1, 2024 Primary and study completion dates: Aug 1, 2026 to Nov 1, 2026v2 Show 1 more changeShow less
    • Primary and study completion dates: Aug 1, 2026 to Nov 1, 2026
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06435286
Lead Sponsor Baylor College of Medicine
Collaborators: William Marsh Rice University, M.D. Anderson Cancer Center, Instituto do Cancer do Estado de São Paulo, Hospital de Cancer de Barretos - Fundacao Pio XII, National Cancer Institute (NCI)
Conditions Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov