Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Bra
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 exper
| Condition(s) | Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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, a |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Baylor College of Medicine |
| Locations | Houston, Texas, United States; Houston, Texas, United States; Barretos, São Paulo, Brazil; São Paulo, São Paulo, Brazil |
| Start date | 2025-02-17 |
| NCT ID | NCT06435286 |
| Official listing | https://clinicaltrials.gov/study/NCT06435286 |