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

NCT05171478 | Recruiting

• 1 other identifier: IRB00280676
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer; Sarcoidosis

Keywords

lung cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Full-field optical coherence tomography DIAGNOSTIC_TEST

Sample obtained during bronchoscopy will be imaged using full-field optical coherence tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Sarcoidosis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Jeffrey Thiboutot, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Thiboutot, MD

CONTACT

410-502-2533; jthibou1@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 29, 2021
• Study Start: December 9, 2021
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)