Full-Field Optical Coherence Tomography (FFOCT) for Evaluation of Bronchoscopic Small Biopsy Specimens
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
This study sets out to register imaging of small biopsy specimens obtained during bronchoscopy using full-field optical coherence tomography against standard histologic evaluation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Standard contraindications bronchoscopy including bleeding disorders, antiplatelet or anticoagulant usage, severe respiratory failure, and clinical instability
Pregnancy
Trial population
Patients undergoing bronchoscopy with diagnostic biopsy per standard of care for any indication.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Full-field optical coherence tomography
Diagnostic testSample obtained during bronchoscopy will be imaged using full-field optical coherence tomography
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov