NCT03494114

Imaging Activated Macrophages in the Lungs

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Ga-EC2115	Ga-EC2115 will be administered by IV injection prior to PET/CT imaging.

Timeline

• Start date: 2018-11-29
• Primary completion: 2019-11-20
• Completion: 2021-01-13
• First posted: 2018-04-11
• Last updated: 2021-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study