Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung (BREATH)

Mauna Kea Technologies

Status: Completed

Conditions: Lung Neoplasms; Disorder Related to Lung Transplantation

Treatments: Device: probe based laser endomicroscopy (pCLE)

Study type: Observational

Funder types: Industry

Identifiers

NCT01793246

MKT_2012_lung_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

99 participants in 2 patient groups

pCLE for Discrete lung lesions

Description:

Patients undergoing bronchoscopy for the diagnosis of a lesion with probe based laser endomicroscopy (pCLE) imaging before biopsy

Treatment:

Device: probe based laser endomicroscopy (pCLE)

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

Treatment:

Device: probe based laser endomicroscopy (pCLE)