NCT06435286 Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
| NCT ID | NCT06435286 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Baylor College of Medicine |
| Condition | Suspected or Known Squamous Cell Neoplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-02-17 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Mimi C Tan, MD, MPH
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT06435286 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Suspected or Known Squamous Cell Neoplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06435286 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06435286 currently recruiting?
Yes, NCT06435286 is actively recruiting participants. Contact the research team at mc2@bcm.edu for enrollment information.
Where is the NCT06435286 trial being conducted?
This trial is being conducted at Houston, United States, Houston, United States, Barretos, Brazil, São Paulo, Brazil.
Who is sponsoring the NCT06435286 clinical trial?
NCT06435286 is sponsored by Baylor College of Medicine. The principal investigator is Mimi C Tan, MD, MPH at Baylor College of Medicine. The trial plans to enroll 200 participants.