Overview

This trial is active, not recruiting.

Conditions lung neoplasms, disorder related to lung transplantation
Treatment probe based laser endomicroscopy (pcle)
Sponsor Mauna Kea Technologies
Start date February 2013
End date October 2016
Trial size 200 participants
Trial identifier NCT01793246, MKT_2012_lung_01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients undergoing bronchoscopy for the diagnosis of a lesion with probe based laser endomicroscopy (pCLE) imaging before biopsy
probe based laser endomicroscopy (pcle) Cellvizio
pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.
Patients undergoing bronchoscopy for the detection of acute rejection of lung transplant with probe based laser endomicroscopy (pCLE) imaging before biopsy
probe based laser endomicroscopy (pcle) Cellvizio
pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.

Primary Outcomes

Measure
Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant.
time frame: Up to 12 months
Diagnostic performance of the pCLE image interpretation criteria for discrete lung lesions and for acute lung rejection in lung transplant.
time frame: Up to 12 months.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs
Principal investigator Cesar Keller, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Mauna Kea Technologies.