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

Completed

Conditions studied: Lung Neoplasms, Disorder Related to Lung Transplantation

In brief

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.

Key facts

Study ID

NCT01793246

Run by

Mauna Kea Technologies

People needed

99

Starts

2013-02-01

Expected to finish

2016-12-24

Last updated by the study team

2017-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Joseph's Medical Center — Phoenix, Arizona, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Columbus Regional Hospital — Columbus, Indiana, United States
• University of Louisiana Shreveport — Shreveport, Louisiana, United States
• Walter Reed Military Medical Center — Bethesda, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Rochester — Rochester, New York, United States
• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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