Clinical trial · Interventional
Pilot Study To Evaluate Optical Frequency Domain Imaging For Diagnosis Of Central Airway Disease
NCT00784329CI-TRIAL-00037553withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the potential of a new imaging device, termed Optical Frequency Domain Imaging (OFDI), in the early diagnosing of pulmonary malignancies in the central airways.
Conditions
Conditions (3)
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 |
| Pulmonary Disease | — | UNRESOLVED | — |
| Squamous Cell Lung Cancer | Lung Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optical Frequency Domain Imaging (OFDI) System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Optical Frequency Domain Imaging
- description
- Optical Frequency Domain Imaging System used during Lung and Bronchial biopsies to detect cancerous tissue. Tissue imaging results will be compared to tissue biopsy results.
- interventionNames
- Device: Optical Frequency Domain Imaging (OFDI) System
Primary outcomes (1)
- measure
- Obtain biopsy correlated OFDI images with the purpose of establishing OFDI image criteria for discrimination of tissue types.
- timeFrame
- One time Bronchoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing bronchoscopy for known or suspected pulmonary malignancy in the central airways * Patients must be over the age of 18 * Patient must be able to give informed consent * Women with child bearing potential must have a negative pregnancy test within seven days prior to the procedure Exclusion Criteria: * PaO2 less than 80 on FiO2 greater 70% * Systolic blood pressure less than 90 * Active bronchospasm * INR greater than 2.0 (INR: International Normalized Ratio) * Recent myocardial infarction within last two weeks * Active cardiac chest pain * Significant untreated sleep apnea * FEV1 less than 30% of predicted (FEV1: forced expiratory volume in 1 second) * Worsening hypercarbia with PaCO2 greater than 55 * In active respiratory failure (unless endotracheal intubation is performed first to stabilize the airway)
References
Publications (10)
- BACKGROUNDJemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43. PMID 17237035
- BACKGROUNDSociety AC. Cancer Facts & Figures 2007. American Cancer Society. Atlanta, 2007
- BACKGROUNDTravis WD, Travis LB, Devesa SS. Lung cancer. Cancer. 1995 Jan 1;75(1 Suppl):191-202. doi: 10.1002/1097-0142(19950101)75:1+3.0.co;2-y. PMID 8000996
- BACKGROUNDKerr KM. Pulmonary preinvasive neoplasia. J Clin Pathol. 2001 Apr;54(4):257-71. doi: 10.1136/jcp.54.4.257. PMID 11304841
- BACKGROUNDHirsch FR, Franklin WA, Gazdar AF, Bunn PA Jr. Early detection of lung cancer: clinical perspectives of recent advances in biology and radiology. Clin Cancer Res. 2001 Jan;7(1):5-22. PMID 11205917
- BACKGROUNDFeller-Kopman D, Lunn W, Ernst A. Autofluorescence bronchoscopy and endobronchial ultrasound: a practical review. Ann Thorac Surg. 2005 Dec;80(6):2395-401. doi: 10.1016/j.athoracsur.2005.04.084. PMID 16305928
- BACKGROUNDMountain CF. Revisions in the International System for Staging Lung Cancer. Chest. 1997 Jun;111(6):1710-7. doi: 10.1378/chest.111.6.1710. PMID 9187198
- BACKGROUNDThiberville L. Nonsurgical therapeutic approach of early lung cancers of the proximal bronchus. European Respiratory Review 2002;12:182-186
- BACKGROUNDSutedja TG, Schreurs AJ, Vanderschueren RG, Kwa B, vd Werf TS, Postmus PE. Bronchoscopic therapy in patients with intraluminal typical bronchial carcinoid. Chest. 1995 Feb;107(2):556-8. doi: 10.1378/chest.107.2.556. PMID 7842794