Imaging Activated Macrophages in the Lungs

Phase 1

Terminated

• Conditions: COPD
• Interventions: Drug: Ga-EC2115

• Registration Number: NCT03494114
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-11
• Study Start: 2018-11-29
• Primary Completion: 2019-11-20
• Study Completion: 2021-01-13
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COPD Patients	Ga-EC2115	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.
Individuals without COPD	Ga-EC2115	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States