Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening: A Clinical Study in Brazil and the United States
Trial ID: NCT06435286
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: PHASE2
Start date: 2025-02-17
Completion date: 2027-03-01
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
Interventions: Proflavine Hemisulfate; Artificial Intelligence Mobile High-Resolution Microendoscope
Locations: Baylor St. Luke's Medical Center; Ben Taub Hospital (Harris Health Systems); Hospital de Cancer de Barretos - Fundacao Pio XII; Instituto do Câncer do Estado de São Paulo
Countries: United States; United States; Brazil; Brazil
Enrollment: 200
Age range: 18 Years - None
Sex: ALL

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.

Eligibility criteria:
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.

Outcomes:
Clinical Impact; Performance Characteristics; Procedure Efficiency; Clinician Confidence