Clinical trial · Observational
Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung
Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs
NCT01793246CI-TRIAL-00029313BREATHcompletedClinicalTrials.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)
Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung lesions or for detection of acute rejection following lung transplants. The hypothesis is that bronchoscopy together with probe-based endomicroscopy (pCLE)results in improved and/or incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disorder Related to Lung Transplantation | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| probe based laser endomicroscopy (pCLE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- pCLE for Discrete lung lesions
- description
- Patients undergoing bronchoscopy for the diagnosis of a lesion with probe based laser endomicroscopy (pCLE) imaging before biopsy
- interventionNames
- Device: probe based laser endomicroscopy (pCLE)
- label
- pCLE for acute lung transplant rejection
- description
- Patients undergoing bronchoscopy for the detection of acute rejection of lung transplant with probe based laser endomicroscopy (pCLE) imaging before biopsy
- interventionNames
- Device: probe based laser endomicroscopy (pCLE)
Primary outcomes (2)
- measure
- Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant.
- timeFrame
- Up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female \> 18 years of age * Willing and able to comply with study procedures and provide written informed consent to participate in the study * Indeterminate discrete nodule(s) suspicious for cancer scheduled for diagnostic bronchoscopy * Newly discovered \&/or prior discovered non classified nodules, hard to define based on CT scan * Purpose of bronchoscopy is for diagnosis of lesion(s) - can be solitary pulmonary nodule or multiple lesions * All lesion locations are acceptable * Any patient undergoing clinically indicated bronchoscopies after lung transplantation * Patients post transplant showing clinical signs of acute rejection \>3 weeks; \< 1 year * Patient with single or double lung transplant Exclusion Criteria: * Contraindication to short-acting anesthetic agents; * Contraindications to transbronchial biopsy * Bleeding diathesis; * A pacemaker/defibrillator; * A diagnosis by other means (sputum cytology, microbiology). * Unwilling To Consent * Unable To Safely Tolerate A Bronchoscopic Procedure * Unwilling To Comply With Surveillance Bronchoscopy Follow Up * Chronic Rejection * Fungal Disease * Ax Histological Assessment Or Incomplete Biopsy Procedure Should Be Considered As A Screen Failure
References
Publications (19)
- BACKGROUNDMeining A, Chen YK, Pleskow D, Stevens P, Shah RJ, Chuttani R, Michalek J, Slivka A. Direct visualization of indeterminate pancreaticobiliary strictures with probe-based confocal laser endomicroscopy: a multicenter experience. Gastrointest Endosc. 2011 Nov;74(5):961-8. doi: 10.1016/j.gie.2011.05.009. Epub 2011 Jul 29. PMID 21802675
- BACKGROUNDSharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13. PMID 21741642
- BACKGROUNDPohl H, Rosch T, Vieth M, Koch M, Becker V, Anders M, Khalifa AC, Meining A. Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett's oesophagus. Gut. 2008 Dec;57(12):1648-53. doi: 10.1136/gut.2008.157461. Epub 2008 Aug 28. PMID 18755886
- BACKGROUNDNewton RC, Kemp SV, Yang GZ, Elson DS, Darzi A, Shah PL. Imaging parenchymal lung diseases with confocal endomicroscopy. Respir Med. 2012 Jan;106(1):127-37. doi: 10.1016/j.rmed.2011.09.009. Epub 2011 Oct 14. PMID 22000588
- BACKGROUNDYick CY, von der Thusen JH, Bel EH, Sterk PJ, Kunst PW. In vivo imaging of the airway wall in asthma: fibered confocal fluorescence microscopy in relation to histology and lung function. Respir Res. 2011 Jun 23;12(1):85. doi: 10.1186/1465-9921-12-85. PMID 21699692
- BACKGROUNDThiberville L, Salaun M, Lachkar S, Dominique S, Moreno-Swirc S, Vever-Bizet C, Bourg-Heckly G. Human in vivo fluorescence microimaging of the alveolar ducts and sacs during bronchoscopy. Eur Respir J. 2009 May;33(5):974-85. doi: 10.1183/09031936.00083708. Epub 2009 Feb 12.