Full-Field Optical Coherence Tomography (FFOCT) for Evaluation of Bronchoscopic Small Biopsy Specimens

This study sets out to register imaging of small biopsy specimens obtained during bronchoscopy using full-field optical coherence tomography against standard histologic evaluation.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Sarcoidosis
• Intervention / Treatment: Diagnostic test: Full-field optical coherence tomography

Detailed Description

Small biopsy specimens obtained through bronchoscopy are commonly employed for the diagnosis and staging of thoracic malignancies. Diagnostic yield is dependent on tissue quality and quantity in specimens obtained through bronchoscopy, and it is thus important to ensure adequate sampling. Rapid on-site cytology (ROSE) is a method used by having a cytotechnologist at the bedside to prepare and analyze specimens to improve the quality of tissue acquisition during bronchoscopy. Although effective, ROSE expertise is not always available to proceduralists, is costly, and reproducible techniques that can be deployed across multiple tiers of institutions are needed across the globe.

Optical coherence tomography (OCT) is an emerging technique which may provide real-time imaging with resolution approaching that of typical histopathology. This has several benefits over ROSE using histopathologic evaluation including rapid imaging with minimal tissue processing, preservation of tissue specimens for molecular testing, enhanced intracellular contrast, and adaptation to machine learning approaches to allow for a reproducible and consistent result. In fact, full-field OCT has recently been applied in several tissue types for evaluation of adequacy of pathologic specimens and evaluation of malignancy, among others. To the best of the investigators' knowledge, this technology has not yet been evaluated for assessment of specimen quality in bronchoscopic procedures.

Thus, the investigators propose a study of full-field OCT for evaluation of small biopsy specimens obtained through bronchoscopy. The investigators aim to demonstrate the feasibility of this technology in the workflow of bronchoscopy and compare to current evaluation methods including rapid on-site evaluation (ROSE). ROSE is commonly used to evaluate adequacy of tissue diagnosis during bronchoscopic procedures including at this institution. However, studies have not shown definitive benefits over bronchoscopy without ROSE, and current expert guidelines suggest bronchoscopy with Endobronchial Ultrasound (EBUS) transbronchial needle aspiration (TBNA) may be performed with or without ROSE.

Full-field OCT has several potential benefits compared to ROSE, including rapid analysis with minimal tissue processing and preservation of tissue for further molecular testing. In addition, OCT has been used to assess surgical biopsy specimens in a non-destructive manner, so the tissues can be analyzed after imaging using standard cytological and pathological methods. Full-field OCT evaluation may be applied to other diseases in addition to further augmenting the diagnostic ability through the use of machine learning approaches.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Jeffrey Thiboutot, MD; Phone Number: 410-502-2533; Email: jthibou1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: IP Research Team; Phone Number: 410-955-6105; Email: ipresearch@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing bronchoscopy with diagnostic biopsy per standard of care for any indication.

Description

Inclusion Criteria:

• Inpatients or outpatients greater than or equal to 18 years old
• Capable of providing informed consent
• Undergoing bronchoscopy for diagnosis or staging per standard of care
• Collection of small biopsy samples by EBUS or conventional transbronchial needle aspiration (TBNA) or transbronchial biopsy for purposes outside of the research study

Exclusion Criteria:

• Standard contraindications bronchoscopy including bleeding disorders, antiplatelet or anticoagulant usage, severe respiratory failure, and clinical instability
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of FFOCT to standard histology as assessed by the kappa value	Correlation of FFOCT to standard histology will be assessed by the kappa value of correlation.	1 year

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Jeffrey Thiboutot, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: lung cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Hypersensitivity; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lymphatic Diseases; Lymphoproliferative Disorders; Hypersensitivity, Delayed; Hemic and Lymphatic Diseases; Lung Neoplasms; Sarcoidosis
• Other Study ID Numbers: IRB00280676

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No