Imaging Activated Macrophages in the Lungs

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.

Study Overview

• Status: Terminated
• Conditions: COPD
• Intervention / Treatment: Drug: Ga-EC2115

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD Patients; 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.	Drug: Ga-EC2115; Ga-EC2115 will be administered by IV injection prior to PET/CT imaging.
Experimental: Individuals without COPD; 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.	Drug: Ga-EC2115; Ga-EC2115 will be administered by IV injection prior to PET/CT imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether the PET signal in the lungs correlates with inflammation in bronchoalveolar lavage (BAL).	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.	1 day (at the time of bronchoscopy following PET scanning)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether the PET signal in lungs can identify differences between patients with COPD and control subjects without COPD.	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).	1 day (at the time of the PET scan)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether the PET signal in lungs correlates with COPD severity.	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).	1 day (at the time of the PET scan)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Endocyte
• Investigators: Principal Investigator: Timothy S Blackwell, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): January 13, 2021

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 180071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No