Imaging Activated Macrophages in the Lungs



Status:Enrolling by invitation
Conditions:Chronic Obstructive Pulmonary Disease
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:50 - 75
Updated:12/6/2018
Start Date:November 29, 2018
End Date:October 31, 2020

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To test whether folate-based positron emission tomography (PET) imaging using 68Ga-EC2115 can
differentiate chronic obstructive pulmonary disease (COPD) patients from control subjects and
determine whether the PET signal correlates with measurements of inflammation and disease
severity.

Investigators intend to enroll patients who are undergoing bronchoscopy for diagnosis of
solitary pulmonary nodules from the Vanderbilt lung nodule evaluation clinic, including 30
patients with COPD and 15 non-smokers without COPD. Folate imaging will be performed with
68Ga-EC2115 prior to scheduled bronchoscopy, which will be performed for clinical purposes to
evaluate a suspicious lung nodule. The unused portion of the bronchoalveolar lavage (not
necessary for clinical purposes), will be interrogated to compare PET imaging with parameters
of inflammation in bronchoalveolar lavage (BAL). In addition, PET imaging data will be
compared with disease severity based on pulmonary function testing.

Inclusion Criteria:

- 50-75 years of age

- Non-smoker or former smoker (quit > 1 year ago)

- Pulmonary function testing done within last 2 years

- For COPD group, forced expiratory volume at one second/forced vital capacity
(FEV1/FVC) ratio < 0.7 and FEV1 < 80% predicted.

- For control group, FEV1/FVC ratio > 0.7 and FEV1 > 80% predicted.

- Scheduled to undergo bronchoscopy for diagnostic evaluation of solitary pulmonary
nodule (< 3 cm in diameter)

Exclusion Criteria:

- Inability to provide informed consent

- Pregnant or lactating women. (Serum pregnancy testing will be required for
pre-menopausal women within 24 hours of PET scanning)

- Active smokers

- Diagnosis of chronic lung disease other than COPD, i.e. - asthma, idiopathic pulmonary
fibrosis

- History of diagnosis or treatment of lung cancer
We found this trial at
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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