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

Launched by BAYLOR COLLEGE OF MEDICINE · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new technology called a mobile high-resolution microendoscope (mHRME) to help detect esophageal cancer, specifically a type called squamous cell neoplasia. The goal is to see how well this technology works in both Brazil and the United States, especially when combined with artificial intelligence (AI) software to improve its ability to find cancerous cells. Researchers want to find out if using this technology can lead to better detection rates and help doctors make more informed decisions about patient care.

To participate in the trial, individuals must be at least 18 years old and undergoing routine screenings for esophageal cancer, particularly those with a history of head or neck cancer, heavy smoking, or other risk factors. Eligible participants should not have advanced esophageal cancer or be pregnant. Those who join the study can expect to undergo standard endoscopy procedures, where a small camera is used to look inside the esophagus, and may have additional tests using the new technology. This trial aims to gather important data that could help improve cancer screening in diverse populations.

Gender

ALL

Eligibility criteria

• 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.