NCT06435286 · Baylor College of Medicine
Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
What this study is about
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 treatment group$1 (100% vs.
View original scientific description
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.
Interventions
DRUG
Proflavine Hemisulfate
Approximately 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.
DEVICE
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 measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
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)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations