Imaging Activated Macrophages in the Lungs

NCT03494114 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 180071
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Other Outcomes (1)

• Determine whether the PET signal in lungs correlates with COPD severity.

  1 day (at the time of the PET scan)

Study Arms (2)

COPD Patients

EXPERIMENTAL

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

Individuals without COPD

EXPERIMENTAL

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

Interventions

Ga-EC2115 DRUG

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

COPD Patients; Individuals without COPD

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Endocyte: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy S Blackwell, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiologist who evaluates the PET scan will be blinded to the to patient groups (COPD versus control)
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Testing whether folate-based imaging using 68 Ga-EC2115 can be used to identify macrophages expressing the high affinity folate receptor (folate receptor beta).

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 11, 2018
• Study Start: November 29, 2018
• Primary Completion: November 20, 2019
• Study Completion: January 13, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)