Status:
COMPLETED
Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung
Lead Sponsor:
Mauna Kea Technologies
Conditions:
Lung Neoplasms
Disorder Related to Lung Transplantation
Eligibility:
All Genders
18+ years
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 to...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 24 2016
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01793246
Start Date
February 1 2013
End Date
December 24 2016
Last Update
August 29 2017
Active Locations (9)
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1
St. Joseph's Medical Center
Phoenix, Arizona, United States, 85013
2
Mayo Clinic
Jacksonville, Florida, United States, 32082
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Columbus Regional Hospital
Columbus, Indiana, United States, 47201