Suspected or Known Squamous Cell NeoplasiaPhase 2NCT06435286
Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
A Phase 2 study testing Proflavine Hemisulfate and Artificial Intelligence Mobile High-Resolution Microendoscope in people with Suspected or Known Squamous Cell Neoplasia and Prior History of Squamous Cell Dysplasia and /or Neoplasia, run by Baylor College of Medicine at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia
- What is being tested?
- Proflavine Hemisulfate and Artificial Intelligence Mobile High-Resolution Microendoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 17 Feb 2025to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Adrianna O Maliga, MPH, 713-798-5987, adrianna.maliga@bcm.edu
Mimi C Tan, MD, MPH
- Recruiting
Ben Taub Hospital (Harris Health Systems)
Houston, Texas, 77030
Adrianna O Maliga, MPH, 713-798-5987, adrianna.maliga@bcm.edu
Mimi C Tan, MD, MPH
Brazil2 sites, 2 recruiting
- Recruiting
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos, São Paulo, 14784-400
Elisa R Baba, MD, PhD, +55-11-98501-9190, erbaba@uol.com.br
Elisa R Baba, MD, PhD
- Recruiting
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
Fauze Maluf-Filho, MD, +55-11-9919-19014, fauze.maluf@terra.com.br
Glaucia F De Lima Pereira, +55-11-3893-3535, glaucia.lima@hc.fm.usp.br
About this study
Official title: Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening: A Clinical Study in Brazil and the United States
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.
Read the detailed description
The investigators' hypothesis is that the artificial intelligence (AI) mobile, high-resolution microendoscope (mHRME) will increase the accuracy of Lugol's chromoendoscopy (LCE) in endoscopic cancer detection in low- and middle-income countries (LMICs) and high-income countries (HICs).
Objective 1: The investigators' first objective is to evaluate the diagnostic performance, efficiency, and impact of this automated optical biopsy device. In a single-arm study (n=200) of high-risk subjects undergoing LCE followed by AI-mHRME for ESCN screening in Brazil and the US, the investigators will evaluate the diagnostic performance and efficiency of this automated optical biopsy device.
The investigators' other hypotheses are that the AI-mHRME will:
- increase the mHRME accuracy in novices and be non-inferior to experts,
- increase user confidence among experts and novices, and
- increase the LCE efficiency and impact byreducing biopsies and second procedures.
The investigators will compare the accuracy of the AI-mHRME software read to novice and expert clinicians' subjective reading to gold-standard histopathology by an expert gastrointestinal (GI) pathologist. For clinician confidence and clinical impact, they will determine the clinician's confidence level in the software diagnosis and the potential clinical impact of this diagnosis among novice and expert endoscopists using AI-mHRME. The clinician reads will be part of the mHRME procedure and treatment "plan" (biopsy vs. not biopsy vs. treat). Clinicians are not considered study subjects in objective 1. The clinical impact will be determined by the change in the clinician's decision in the treatment "plan" before and after the AI-mHRME read. For efficiency (biopsy saving and diagnostic yield), they will determine the number of patients spared any biopsy due to AI-mHRME. The investigators will compare the diagnostic yield of AI-mHRME and LCE vs. LCE alone (diagnostic yield = neoplastic biopsies/total number of biopsies obtained in biopsied patients).
Objective 2: This objective will have three study populations, with a total sample size of n=50 subjects. To determine barriers and facilitators to implementing AI-mHRME, the team will form Health Sector Stakeholder Advisory Boards (HS-SAB) in the US and Brazil as the first study population. The HS-SABs will include academic partners, primary care providers referring patients, doctors performing esophageal cancer screening, hospital administrators, and patient and caregiver representatives. The HS-SAB sample size will be 6-10 members in the US and Brazil each, a standard number of participants for research advisory boards. The team will collect feedback and input through focus group discussions (FGDs) at 6 time points across the project period per HS-SAB. FGD objectives will match the research stage: clinical trial planning (recruitment and retention plan refinement), data collection (stakeholders identification), result interpretation, and dissemination.
For the second study population, the team will conduct semi-structured individual interviews with implementers to assess barriers and facilitators to implementing AI-assisted cancer technologies (n=40). Interviews will be with patients and caregivers(n=10), GI clinicians (n=10), primary care physicians (n=10), and hospital and health leadership (n=10).
There will be surveys with endoscopists (n=40) at the participating sites to understand their thoughts on HRME.
- Conditions
- Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia
- Being tested
- Proflavine Hemisulfate, Artificial Intelligence Mobile High-Resolution Microendoscope
- Keywords
- Squamous cell neoplasia, Proflavine, Lugol's chromoendoscopy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proflavine HemisulfateDrug
Also called Proflavine
Approximately 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.
Artificial Intelligence Mobile High-Resolution MicroendoscopeDevice
Also called AI-mHRME
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Proflavine Hemisulfate; Device: Artificial Intelligence Mobile High-Resolution Microendoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Impact
Change in clinical plan ('biopsy vs. no biopsy vs. treat') following AI-mHRME.
Measured: 18 months
Performance Characteristics
Sensitivity, specificity, positive and negative predictive values of AI-mHRME.
Measured: 18 months
Procedure Efficiency
Efficiency in the number of biopsies saved, procedures saved.
Measured: 18 months
Clinician Confidence
Confidence of expert and novice clinicians in clinically interpreting mHRME (pre- and post-use of AI-mHRME).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start17 Feb 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected or Known Squamous Cell NeoplasiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- William Marsh Rice University, M.D. Anderson Cancer Center, Instituto do Cancer do Estado de São Paulo, Hospital de Cancer de Barretos - Fundacao Pio XII, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mimi Chang Tan, Baylor College of Medicine
- Investigators
- Mimi C Tan, MD, MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435286
- Sponsor's protocol ID
- H-53483
- Status last verified
- Sep 2025
- First submitted
- 24 May 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening: A Clinical Study in Brazil and the United States
- ClinicalTrials.gov ID
- NCT06435286
- Acronym / sponsor ID
- H-53483
- Conditions
- Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia
- Keywords
- Squamous cell neoplasia, Proflavine, Lugol's chromoendoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- William Marsh Rice University, M.D. Anderson Cancer Center, Instituto do Cancer do Estado de São Paulo, Hospital de Cancer de Barretos - Fundacao Pio XII, National Cancer Institute (NCI)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators' hypothesis is that the artificial intelligence (AI) mobile, high-resolution microendoscope (mHRME) will increase the accuracy of Lugol's chromoendoscopy (LCE) in endoscopic cancer detection in low- and middle-income countries (LMICs) and high-income countries (HICs).
Objective 1: The investigators' first objective is to evaluate the diagnostic performance, efficiency, and impact of this automated optical biopsy device. In a single-arm study (n=200) of high-risk subjects undergoing LCE followed by AI-mHRME for ESCN screening in Brazil and the US, the investigators will evaluate the diagnostic performance and efficiency of this automated optical biopsy device.
The investigators' other hypotheses are that the AI-mHRME will:
- increase the mHRME accuracy in novices and be non-inferior to experts,
- increase user confidence among experts and novices, and
- increase the LCE efficiency and impact byreducing biopsies and second procedures.
The investigators will compare the accuracy of the AI-mHRME software read to novice and expert clinicians' subjective reading to gold-standard histopathology by an expert gastrointestinal (GI) pathologist. For clinician confidence and clinical impact, they will determine the clinician's confidence level in the software diagnosis and the potential clinical impact of this diagnosis among novice and expert endoscopists using AI-mHRME. The clinician reads will be part of the mHRME procedure and treatment "plan" (biopsy vs. not biopsy vs. treat). Clinicians are not considered study subjects in objective 1. The clinical impact will be determined by the change in the clinician's decision in the treatment "plan" before and after the AI-mHRME read. For efficiency (biopsy saving and diagnostic yield), they will determine the number of patients spared any biopsy due to AI-mHRME. The investigators will compare the diagnostic yield of AI-mHRME and LCE vs. LCE alone (diagnostic yield = neoplastic biopsies/total number of biopsies obtained in biopsied patients).
Objective 2: This objective will have three study populations, with a total sample size of n=50 subjects. To determine barriers and facilitators to implementing AI-mHRME, the team will form Health Sector Stakeholder Advisory Boards (HS-SAB) in the US and Brazil as the first study population. The HS-SABs will include academic partners, primary care providers referring patients, doctors performing esophageal cancer screening, hospital administrators, and patient and caregiver representatives. The HS-SAB sample size will be 6-10 members in the US and Brazil each, a standard number of participants for research advisory boards. The team will collect feedback and input through focus group discussions (FGDs) at 6 time points across the project period per HS-SAB. FGD objectives will match the research stage: clinical trial planning (recruitment and retention plan refinement), data collection (stakeholders identification), result interpretation, and dissemination.
For the second study population, the team will conduct semi-structured individual interviews with implementers to assess barriers and facilitators to implementing AI-assisted cancer technologies (n=40). Interviews will be with patients and caregivers(n=10), GI clinicians (n=10), primary care physicians (n=10), and hospital and health leadership (n=10).
There will be surveys with endoscopists (n=40) at the participating sites to understand their thoughts on HRME.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging | Experimental | Drug: Proflavine Hemisulfate, Device: Artificial Intelligence Mobile High-Resolution MicroendoscopeAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proflavine HemisulfateAlso: ProflavineApproximately 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. | Drug | Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging |
| Artificial Intelligence Mobile High-Resolution MicroendoscopeAlso: AI-mHRMEThe 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. | Device | Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging |
Primary outcome
Clinical Impact
Time frame: 18 months
Change in clinical plan ('biopsy vs. no biopsy vs. treat') following AI-mHRME.
Performance Characteristics
Time frame: 18 months
Sensitivity, specificity, positive and negative predictive values of AI-mHRME.
Procedure Efficiency
Time frame: 18 months
Efficiency in the number of biopsies saved, procedures saved.
Clinician Confidence
Time frame: 18 months
Confidence of expert and novice clinicians in clinically interpreting mHRME (pre- and post-use of AI-mHRME).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mimi C Tan, MD, MPH principal investigator
Baylor College of Medicine
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proflavine Hemisulfate and Artificial Intelligence Mobile High-Resolution Microendoscope in people with Suspected or Known Squamous Cell Neoplasia and Prior History of Squamous Cell Dysplasia and /or Neoplasia, run by Baylor College of Medicine at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mimi C Tan, MD, MPH (7137980950, mc2@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Impact (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.