Disorder Related to Lung Transplantation, Lung Neoplasms
Conditions
Keywords
lung cancer, lung neoplasms, lung transplant
Brief summary
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.
Detailed description
The primary aim of this study is to develop the criteria to differentiate healthy versus diseased tissue in patient with discrete lung lesions or to characterize acute lung rejection in patients with transplanted lungs. Once these criteria have been defined, the diagnostic parameters and the reproducibility of pCLE will be assessed.
Interventions
DEVICEprobe based laser endomicroscopy (pCLE)
pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.
Sponsors
Mauna Kea Technologies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant. | Up to 12 months | For Group 1 - Discrete lung lesions |
| Diagnostic performance of the pCLE image interpretation criteria for discrete lung lesions and for acute lung rejection in lung transplant. | Up to 12 months. | For Group 2 - Transplant rejection |
Countries
United States
Outcome results
None listed