Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening: A Clinical Study in Brazil and the United States
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Texas
Baylor St. Luke's Medical Center
RECRUITING
Houston
Ben Taub Hospital (Harris Health Systems)
RECRUITING
Houston
Other Locations
Brazil
Hospital de Cancer de Barretos - Fundacao Pio XII
RECRUITING
Barretos
Instituto do Câncer do Estado de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Sharmila Anandasabapathy, MD
sharmila.anandasabapathy@bcm.edu
7137980950
Backup
Adrianna O Maliga, MPH
adrianna.maliga@bcm.edu
(713) 798-5987
Time Frame
Start Date:2025-02-17
Estimated Completion Date:2027-03-01
Participants
Target number of participants:200
Treatments
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.
Collaborators: William Marsh Rice University, Instituto do Cancer do Estado de São Paulo, Hospital de Cancer de Barretos - Fundacao Pio XII, National Cancer Institute (NCI), M.D. Anderson Cancer Center