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An Artificial-Intelligence Mobile High-Resolution Microendoscope for the Screening of Esophageal Cancer
Trial Status: active
This phase II trial studies how well an artificial-intelligence mobile high-resolution microendoscope (AI-mHRME) works for the screening of esophageal cancer. Upper endoscopy is often used during screening for esophageal cancer. It is a procedure that places a long, bendable tube with a light and camera (probe) down the throat to check the esophagus. During an endoscopy using an AI-mHRME, a powerful microscope is used to take pictures of areas of the esophagus that may be of concern. The microscope is linked to artificial intelligence (AI). AI is a computer software program that can perform human tasks. It identifies and assists doctors in finding abnormal cells. A staining dye called proflavine hemisulfate (proflavine) is also used to dye the esophagus where any abnormal areas are identified to help doctors better see the cells when the probe is against the esophageal lining. Using an AI-mHRME during screening endoscopy may be an effective way to identify esophageal cancer.
Inclusion Criteria
ESOPHAGEAL HRME CLINICAL TRIAL: Subjects or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent per institutional and federal guidelines
ESOPHAGEAL HRME CLINICAL TRIAL: Patients must be undergoing routine (standard of care) LCE screening for esophageal squamous cell carcinoma (ESCC) (patients with known history of head/neck squamous cancer are also eligible)
ESOPHAGEAL HRME CLINICAL TRIAL: Patients must be > 18 years old
HEALTH SECTOR STAKEHOLDER ADVISORY BOARDS (HS-SABs): Academic partners, primary care providers for referring institutions, clinicians performing esophageal cancer screening and treatment, hospital administrators, and patient and caregiver representatives
HS-SABs: Participants > 18 years old
HS-SABs: Participants of any sex or gender
HS-SABs: Participants who are willing and able to give informed consent
HS-SABs: Participants who are willing to participate in 6 focus group discussions
HS-SABs: Women (if they are in any of the professions or roles listed above) who are pregnant or breastfeeding
SEMI-STRUCTURED INTERVIEWS (SSIs): Participants > 18 years old
SSIs: Participants of any sex or gender
SSIs: Participants who are willing and able to give informed consent
SSIs: Participants who are willing to participate in the semi-structured interview and identified by a member of one of the HS-SABs
ENDOSCOPISTS SURVEYS: Participants > 18 years old
ENDOSCOPISTS SURVEYS: Participants of any sex or gender
ENDOSCOPISTS SURVEYS: Endoscopists participating in the trial at each site
ENDOSCOPISTS SURVEYS: Does not have to have experience using an HRME device
Exclusion Criteria
ESOPHAGEAL HRME CLINICAL TRIAL: Allergy or prior reaction to proflavine or iodine
ESOPHAGEAL HRME CLINICAL TRIAL: 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
ESOPHAGEAL HRME CLINICAL TRIAL: Patient unable to undergo routine endoscopy with biopsy
ESOPHAGEAL HRME CLINICAL TRIAL: Women who are pregnant or breastfeeding
ESOPHAGEAL HRME CLINICAL TRIAL: Prothrombin time (PT) greater than 50% of control
ESOPHAGEAL HRME CLINICAL TRIAL: Prothrombin time test (PTT) greater than 50 seconds (sec)
ESOPHAGEAL HRME CLINICAL TRIAL: International normalized ratio (INR) greater than 2.0
ESOPHAGEAL HRME CLINICAL TRIAL: Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues
HS-SABs: If they do not agree to participate in the focus group discussions
HS-SABs: Those who do not have any contact with endoscopy procedures
* Doctors who have never performed endoscopies
* Patients who never had an endoscopy or did not have ESCN
* Administrators from other departments where endoscopies are unrelated
HS-SABs: If they are unable to attend six focus group discussions
SSIs: Participants < 18 years old
SSIs: Participants who are unwilling and unable to participate in the interview
ENDOSCOPISTS SURVEYS: Participants < 18 years old
ENDOSCOPISTS SURVEYS: Endoscopist not at a participating study site
Additional locations may be listed on ClinicalTrials.gov for NCT06435286.
Locations matching your search criteria
United States
Texas
Houston
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Ie. Procedure efficiency (number of patients correctly saved any biopsy and the total number of biopsies saved).
SECONDARY OBJECTIVE:
I. To use a stakeholder-engaged approach to evaluate the barriers, acceptability, appropriateness, and feasibility of using AI-mHRME for esophageal squamous cell neoplasia (ESCN) management and to determine contextual factors influencing its adoption in the four diverse hospital settings in the United States of America (USA) and Brazil.
OUTLINE:
Patients receive proflavine topically to the esophageal mucosa via spray catheter and then undergo high-resolution microendoscopy (HRME) using AI-mHRME during standard of care (SOC) Lugol’s chromoendoscopy (LCE). Patients also undergo esophageal biopsy on study.
After completion of study intervention, patients are followed up at 7 days.
Trial PhasePhase II
Trial Typescreening
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
