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

NCT06435286 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: H-53483
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 4

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

Keywords

Squamous cell neoplasia; Proflavine; Lugol's chromoendoscopy

Outcome Measures

Primary Outcomes (4)

• Clinical Impact

  Change in clinical plan ('biopsy vs. no biopsy vs. treat') following AI-mHRME.

  18 months

• Performance Characteristics

  Sensitivity, specificity, positive and negative predictive values of AI-mHRME.

  18 months

• Procedure Efficiency

  Efficiency in the number of biopsies saved, procedures saved.

  18 months

• Clinician Confidence

  Confidence of expert and novice clinicians in clinically interpreting mHRME (pre- and post-use of AI-mHRME).

  18 months

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: Proflavine Hemisulfate; Device: Artificial Intelligence Mobile High-Resolution Microendoscope

Interventions

Artificial Intelligence Mobile High-Resolution Microendoscope DEVICE

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.

Also known as: AI-mHRME

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

Proflavine Hemisulfate DRUG

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

Also known as: Proflavine

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• William Marsh Rice University: collaborator
• M.D. Anderson Cancer Center: collaborator
• Instituto do Cancer do Estado de São Paulo: collaborator
• Hospital de Cancer de Barretos - Fundacao Pio XII: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

RECRUITING

Ben Taub Hospital (Harris Health Systems)

Houston, Texas, 77030, United States

RECRUITING

Hospital de Cancer de Barretos - Fundacao Pio XII

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Proflavine

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mimi C Tan, MD, MPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mimi C Tan, MD, MPH

CONTACT

7137980950; mc2@bcm.edu

Adrianna O Maliga, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine - Gastroenterology

Model Details: Participants will be enrolled based on criteria for surveillance or screening for esophageal squamous cell carcinoma. They will receive standard-of-care endoscopy and the artificial intelligence mobile high-resolution microendoscopy procedures.

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2025-09

Locations

BR (2); US (2)