COPD
Conditions
Brief summary
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.
Detailed description
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 patients without COPD. Folate imaging will be performed with 68Ga-EC2115 within one week prior to scheduled bronchoscopy or from 1 week to 6 months after scheduled bronchoscopy, which will be performed for clinical purposes. 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.
Interventions
DRUGGa-EC2115
Ga-EC2115 will be administered by IV injection prior to PET/CT imaging.
Sponsors
Endocyte
Vanderbilt University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
The radiologist who evaluates the PET scan will be blinded to the to patient groups (COPD versus control)
Intervention model description
Testing whether folate-based imaging using 68 Ga-EC2115 can be used to identify macrophages expressing the high affinity folate receptor (folate receptor beta).
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥45 years of age * 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) * Diagnosis of chronic lung disease other than COPD, i.e. - asthma, idiopathic pulmonary fibrosis * History of diagnosis or treatment of lung cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether the PET signal in the lungs correlates with inflammation in bronchoalveolar lavage (BAL). | 1 day (at the time of bronchoscopy following PET scanning) | We will compare the PET signal from 68 Ga-EC2115 in the lungs (opposite lung to the one containing a lung nodule) to the number of macrophages and other inflammatory cells obtained by BAL, particularly those expressing folate receptor beta. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether the PET signal in lungs can identify differences between patients with COPD and control subjects without COPD. | 1 day (at the time of the PET scan) | We will compare the PET signal from 68 Ga-EC2115 in the lungs (opposite lung to the one containing a lung nodule) of patients with COPD and control subjects without COPD (based on pulmonary function testing). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determine whether the PET signal in lungs correlates with COPD severity. | 1 day (at the time of the PET scan) | We will compare the PET signal from 68 Ga-EC2115 in the lungs (opposite lung to the one containing a lung nodule) of COPD patients and determine whether there is a correlation between PET signal and severity of COPD based on FEV1 (percent of predicted). |
Countries
United States
Outcome results
None listed