Clinical trial NCT03494114: Imaging Activated Macrophages in the Lungs
Official title: Imaging Activated Macrophages in the Lungs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: COPD
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Endocyte
First posted: 2018-04-11
Enrollment: 13
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine whether the PET signal in the lungs correlates with inflammation in bronchoalveolar lavage (BAL).
timeFrame: 1 day (at the time of bronchoscopy following PET scanning)
Secondary outcomes:
measure: Determine whether the PET signal in lungs can identify differences between patients with COPD and control subjects without COPD.
timeFrame: 1 day (at the time of the PET scan)
Other outcomes:
measure: Determine whether the PET signal in lungs correlates with COPD severity.
timeFrame: 1 day (at the time of the PET scan)
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Timothy S Blackwell, MD
role: PRINCIPAL_INVESTIGATOR
References: