Clinical trial · Observational
Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer
NCT01039311CI-TRIAL-00009247OCTterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to enroll subjects
Summary
Brief summary (as posted)
Optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide images with good sensitivity and specificity to determine the presence of endobronchial malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optical Coherence Tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Optical Coherence Tomography
- description
- Examine OCT images and compare them to conventional biopsies in same subject.
- interventionNames
- Device: Optical Coherence Tomography
Primary outcomes (1)
- measure
- OCT image sensitivity and specificity in diagnosis of lung cancer.
- timeFrame
- Every 3 months
Secondary outcomes (1)
- measure
- Feasibility and safety of obtaining OCT images during flexible bronchoscopy.
- timeFrame
- Every 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects 18-99 years of age * Presence of an endobronchial mass * Need for flexible bronchoscopy, with endobronchial biopsies Exclusion Criteria: * PCO2 \> 47 mm Hg, and/or long term Oxygen therapy * Unwillingness to undergo fiberoptic bronchoscopy * Coagulopathy, defined as a platelets count \< 100.000/mm3, or an INR\> 1.4, or known clinical bleeding disorder * Therapy with anticoagulant, including Coumadin and Clopidogrel * Renal dysfunction, defined as a Creatinine \> 2 mg/dl * Life-threatening arrhythmias, or history of myocardial infarction within 6 months * Cerebrovascular Accident within the preceding 6 months * Facial abnormality preventing safe introduction of the bronchoscope * Uncontrolled hypertension * Active liver disease * Pregnancy or Breastfeeding * Prisoners * Inability to give informed consent
References
Publications (1)
- DERIVEDMichel RG, Kinasewitz GT, Fung KM, Keddissi JI. Optical coherence tomography as an adjunct to flexible bronchoscopy in the diagnosis of lung cancer: a pilot study. Chest. 2010 Oct;138(4):984-8. doi: 10.1378/chest.10-0753. Epub 2010 May 14. PMID 20472863