Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening

NCT05396781 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: H-44015
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 2

Brief Summary

The investigators have a current trial in China and the US which provides significant support for the safety, cost-effectiveness, accuracy and efficiency of a high resolution microendoscope (HRME)-guided approach in the hands of experienced clinicians. To improve functionality, portability and broader use of this device by non-experts, the investigators recently developed a prototype marHRME platform with an automated, augmented reality (AR)-interpretation that provides an overlaid endoscopic + micro-endoscopic view, facilitating diagnosis and biopsy targeting.

Conditions

Suspected or Known Squamous Cell Neoplasia; Prior History of Squamous Cell Dysplasia and /or Neoplasia

Keywords

Squamous cell neoplasia; Proflavine; Lugol's chromoendoscopy

Outcome Measures

Primary Outcomes (3)

• Diagnostic yield

  The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies.

  Day 1

• 'Patient saved'

  The number of patients who received no biopsies.

  Day 1

• Procedure time

  Total procedure time added by the HRME imaging.

  During Procedure

Secondary Outcomes (1)

• Clinical impact

  Day 1

Other Outcomes (1)

• Performance Characteristics

  Day 1

Study Arms (1)

Augmented Reality High Resolution Microendoscope (HRME) imaging

EXPERIMENTAL

All study subjects will receive White Light Imaging and Lugol's Chromoendoscopy (LCE) which is the current standard of care procedure. The investigators will record any LCE abnormal areas and record the clinician's plan of action. Following LCE, all subjects will receive Mobile, Augmented Reality High Resolution Microendoscope (marHRME) imaging with the study contrast agent (Proflavine) of any LCE-identified abnormal areas as well as LCE normal areas. The investigators will record the subjective clinician read and confidence level in the investigators' diagnosis, and plan of action. Then the investigators will image the same abnormal and normal areas with the marHRME and record the software read, clinician confidence level, and plan of action. Finally, the imaged areas will be biopsied or resected and evaluated by a pathologist. All subjects will receive both standard of care and marHRME imaging.

Drug: Proflavine; Device: Mobile, Augmented High Resolution Microendoscope

Interventions

Proflavine DRUG

5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.

Also known as: proflavine hemisulfate

Augmented Reality High Resolution Microendoscope (HRME) imaging

Mobile, Augmented High Resolution Microendoscope DEVICE

The marHRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.

Also known as: marHRME

Augmented Reality High Resolution Microendoscope (HRME) imaging

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment including patients with known history of head/neck squamous cell cancer.
• Patients must be \>18 years old and able to give informed consent.
• For the provider surveys and interviews, all providers (clinicians, trainees) who are working on the project will be eligible to participate.

You may not qualify if:

• Allergy or prior reaction to the fluorescent contrast agent proflavine
• Patients who are unable to give informed consent
• Known advanced squamous cell carcinoma of the distal esophagus, or dyplastic/suspected malignant esophageal lesion greater than or equal to 2cm in size not amenable to endoscopic therapy
• Patient unable to undergo routine endoscopy with biopsy
• Women who are pregnant or breastfeeding
• Prothrombin time greater than 50% of control; Partial Thromboplastin Time greater than 50 sec, or International Normalized Ratio greater than 2.0
• inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues
• Providers will be excluded if they decline participation or otherwise opt out of the proposed research project.

Sponsors & Collaborators

• Anandasabapathy, Sharmila, M.D.: lead
• William Marsh Rice University: collaborator
• Baylor College of Medicine: collaborator
• University of Sao Paulo: collaborator

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Sao Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Proflavine

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sharmila Anandasabapathy, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: May 31, 2022
• Study Start: January 13, 2022
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

BR (1); US (1)