Using advanced imaging to evaluate small lung biopsy samples
Official title: Full-Field Optical Coherence Tomography (FFOCT) for Evaluation of Bronchoscopic Small Biopsy Specimens
Run by Johns Hopkins University · NCT05171478 · Data updated 2026-11-12
This study is testing a new imaging method to see if it can improve the quality of small lung biopsy samples taken during bronchoscopy for patients being checked for lung cancer or sarcoidosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | December 9, 2021 |
| Main results expected | December 8, 2026 |
| Study ends | December 8, 2026 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT05171478 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are undergoing bronchoscopy for diagnosis or staging of lung conditions.
✕Probably not a fit
Patients with contraindications to bronchoscopy, such as severe respiratory failure or bleeding disorders, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the quality of small biopsy specimens obtained during bronchoscopy using full-field optical coherence tomography (FFOCT) compared to standard histologic evaluation. The study focuses on improving diagnostic yield for lung cancer and sarcoidosis by utilizing FFOCT, which offers real-time imaging with high resolution and minimal tissue processing. This method could enhance the quality of tissue acquisition and preserve specimens for further molecular testing, addressing the limitations of current rapid on-site cytology techniques. The study will include patients undergoing bronchoscopy for diagnosis or staging, with the goal of establishing a reproducible imaging technique applicable across various healthcare settings.
Why it matters
Potential benefit: If successful, this approach could significantly improve the accuracy and efficiency of lung cancer and sarcoidosis diagnoses.
How similar studies have gone: While FFOCT has shown promise in other tissue types, its application in bronchoscopic procedures for specimen quality assessment is novel and has not been previously evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Johns Hopkins Hospital
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Jeffrey Thiboutot, MD — Johns Hopkins University
- Study coordinator: Jeffrey Thiboutot, MD
- Email: jthibou1@jhmi.edu
- Phone: 410-502-2533
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.