Imaging Activated Macrophages in the Lungs

Vanderbilt University Medical Center

Status and phase: Terminated; Phase 1

Conditions: COPD

Treatments: Drug: Ga-EC2115

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03494114

180071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

COPD Patients

Experimental group

Description:

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 BAL, including the number/percentage of macrophages expressing FRβ. In addition, PET imaging data will be compared with disease severity, based on pulmonary function testing.

Treatment:

Drug: Ga-EC2115

Individuals without COPD

Experimental group

Description:

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 BAL, including the number/percentage of macrophages expressing FRβ.

Treatment:

Drug: Ga-EC2115