Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung
- Conditions
- Disorder Related to Lung TransplantationLung Neoplasms
- Interventions
- Device: probe based laser endomicroscopy (pCLE)
- Registration Number
- NCT01793246
- Lead Sponsor
- Mauna Kea Technologies
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description pCLE for Discrete lung lesions probe based laser endomicroscopy (pCLE) Patients undergoing bronchoscopy for the diagnosis of a lesion with probe based laser endomicroscopy (pCLE) imaging before biopsy pCLE for acute lung transplant rejection probe based laser endomicroscopy (pCLE) Patients undergoing bronchoscopy for the detection of acute rejection of lung transplant with probe based laser endomicroscopy (pCLE) imaging before biopsy
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
University of Chicago
🇺🇸Chicago, Illinois, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Columbus Regional Hospital
🇺🇸Columbus, Indiana, United States
University of Rochester
🇺🇸Rochester, New York, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Walter Reed Military Medical Center
🇺🇸Bethesda, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Louisiana Shreveport
🇺🇸Shreveport, Louisiana, United States
St. Joseph's Medical Center
🇺🇸Phoenix, Arizona, United States