Using advanced imaging to evaluate small lung biopsy samples
Full-Field Optical Coherence Tomography (FFOCT) for Evaluation of Bronchoscopic Small Biopsy Specimens
Johns Hopkins University · NCT05171478
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05171478 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing bronchoscopy for diagnosis or staging of lung conditions.
Not a fit: Patients with contraindications to bronchoscopy, such as severe respiratory failure or bleeding disorders, may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Cancer, Sarcoidosis, lung cancer