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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Francisco Alvarez, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Francisco Alvarez, M.D.

Closed for enrollment

More information

Publications

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