Imaging Activated Macrophages in the Lungs

COPD Clinical Trial

Official title:

Imaging Activated Macrophages in the Lungs

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03494114
• Other study ID #: 180071
• Status: Terminated
• Phase: Phase 1
• Start date: November 29, 2018
• Est. completion date: January 13, 2021

Study information

• Verified date: August 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 13, 2021
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Endocyte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)