Recruiting
Phase 2

Optical Biopsy

Sponsor:

Baylor College of Medicine

Code:

NCT06435286

Conditions

Suspected or Known Squamous Cell Neoplasia

Prior History of Squamous Cell Dysplasia and /or Neoplasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Proflavine Hemisulfate

Artificial Intelligence Mobile High-Resolution Microendoscope

Study Details

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.

Conditions

Suspected or Known Squamous Cell Neoplasia

Prior History of Squamous Cell Dysplasia and /or Neoplasia

Study ID

NCT06435286

Start date

Feb 17, 2025

Status verified date

Sep, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging

All subjects will receive White Light Imaging (WLI) and Lugol's Chromoendoscopy (LCE), the current standard of care (SOC) procedure. Following LCE, all subjects will receive the artificial intelligence (AI) mobile high-resolution microendoscopy (mHRME) imaging with Proflavine Hemisulfate of any LCE abnormal and LCE normal areas (4:1 ratio). For both WLI and LCE, we will record the subjective clinician read (neoplastic, non-neoplastic), the confidence level in their diagnoses (high, low), and the action plan (biopsy vs. no biopsy vs. treat). With the AI-mHRME, we will image the same LCE abnormal and normal areas and record the software read, the clinician confidence level, and action plan. Finally, the imaged LCE abnormal areas will be biopsied or resected, and evaluated by a pathologist.

Interventions

Proflavine Hemisulfate

Approximately 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.

Artificial Intelligence Mobile High-Resolution Microendoscope

The AI-mHRME will be inserted through the endoscope biopsy channel and gently placed against the mucosa where proflavine was sprayed. The probe will transmit images to the computer/laptop for the clinician to observe any abnormal tissues and save photos of these tissues.

Primary outcome measure

  • Clinical Impact [ Time Frame: 18 months ]
  • Performance Characteristics [ Time Frame: 18 months ]
  • Procedure Efficiency [ Time Frame: 18 months ]
  • Clinician Confidence [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Mimi C Tan, MD, MPH

7137980950mc2@bcm.edu

Adrianna O Maliga, MPH

(713) 798-5987adrianna.maliga@bcm.edu

Locations

Baylor St. Luke's Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Adrianna O Maliga, MPH

713-798-5987adrianna.maliga@bcm.edu

Principal Investigator:

Mimi C Tan, MD, MPH

Ben Taub Hospital (Harris Health Systems)

Recruiting

Houston, Texas, United States, 77030

Contacts

Adrianna O Maliga, MPH

713-798-5987adrianna.maliga@bcm.edu

Principal Investigator:

Mimi C Tan, MD, MPH

More Information

Sponsor

Baylor College of Medicine

Last update posted

Mar 2, 2026

Last verified

Sep, 2025

Keywords

  • Squamous cell neoplasia
  • Proflavine
  • Lugol's chromoendoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-03-02.