Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435286
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-24
Brief Title:
Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 005 In the screening arm diagnostic yield neoplastic biopsiestotal biopsies increased 36 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 Lugols 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 Lugols 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 n200 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
1 increase the mHRME accuracy in novices and be non-inferior to experts
2 increase user confidence among experts and novices and
3 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 clinicians 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 clinicians 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 biopsiestotal number of biopsies obtained in biopsied patients
Objective 2 This objective will have three study populations with a total sample size of n50 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 n40 Interviews will be with patients and caregiversn10 GI clinicians n10 primary care physicians n10 and hospital and health leadership n10
There will be surveys with endoscopists n40 at the participating sites to understand their thoughts on HRME
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 n200 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
1 increase the mHRME accuracy in novices and be non-inferior to experts
2 increase user confidence among experts and novices and
3 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 clinicians 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 clinicians 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 biopsiestotal number of biopsies obtained in biopsied patients
Objective 2 This objective will have three study populations with a total sample size of n50 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 n40 Interviews will be with patients and caregiversn10 GI clinicians n10 primary care physicians n10 and hospital and health leadership n10
There will be surveys with endoscopists n40 at the participating sites to understand their thoughts on HRME
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None