Trial Title:
Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
NCT ID:
NCT06435286
Condition:
Suspected or Known Squamous Cell Neoplasia
Prior History of Squamous Cell Dysplasia and /or Neoplasia
Conditions: Official terms:
Esophageal Neoplasms
Neoplasms
Proflavine
Conditions: Keywords:
Squamous cell neoplasia
Proflavine
Lugol's chromoendoscopy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention 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.
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Proflavine Hemisulfate
Description:
Approximately 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal
mucosa.
Arm group label:
Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging
Other name:
Proflavine
Intervention type:
Device
Intervention name:
Artificial Intelligence Mobile High-Resolution Microendoscope
Description:
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.
Arm group label:
Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging
Other name:
AI-mHRME
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 <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:
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 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Baylor St. Luke's Medical Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Adrianna O Maliga, MPH
Phone:
713-798-5987
Email:
adrianna.maliga@bcm.edu
Investigator:
Last name:
Sharmila Anandasabapathy, MD
Email:
Principal Investigator
Facility:
Name:
Ben Taub Hospital (Harris Health Systems)
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Adrianna O Maliga, MPH
Phone:
713-798-5987
Email:
adrianna.maliga@bcm.edu
Investigator:
Last name:
Mimi C Tan, MD, MPH
Email:
Principal Investigator
Facility:
Name:
Hospital de Cancer de Barretos - Fundacao Pio XII
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Contact:
Last name:
Elisa R Baba, MD, PhD
Phone:
+55-11-98501-9190
Email:
erbaba@uol.com.br
Investigator:
Last name:
Elisa R Baba, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Claudio Hashimoto, MD, MBA
Email:
Sub-Investigator
Facility:
Name:
Instituto do Câncer do Estado de São Paulo
Address:
City:
São Paulo
Zip:
01246-000
Country:
Brazil
Contact:
Last name:
Fauze Maluf-Filho, MD
Phone:
+55-11-9919-19014
Email:
fauze.maluf@terra.com.br
Contact backup:
Last name:
Elaine U Uehara, MS
Phone:
+55-11-3893-3535
Email:
elaine.uuehara@hc.fm.usp.br
Investigator:
Last name:
Fauze Maluf-Filho, MD
Email:
Principal Investigator
Investigator:
Last name:
Evandro Sobroza de Mello, MD
Email:
Sub-Investigator
Start date:
November 1, 2024
Completion date:
November 1, 2026
Lead sponsor:
Agency:
Baylor College of Medicine
Agency class:
Other
Collaborator:
Agency:
William Marsh Rice University
Agency class:
Other
Collaborator:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Instituto do Cancer do Estado de São Paulo
Agency class:
Other
Collaborator:
Agency:
Hospital de Cancer de Barretos - Fundacao Pio XII
Agency class:
Other
Source:
Baylor College of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435286
