ClinicalTrials.gov
ClinicalTrials.gov Menu

Imaging Activated Macrophages in the Lungs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03494114
Recruitment Status : Enrolling by invitation
First Posted : April 11, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Endocyte
Information provided by (Responsible Party):
Timothy Blackwell, 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.

Condition or disease Intervention/treatment Phase
COPD Drug: Ga-EC2115 Phase 1

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 non-smokers 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 bronchoalveolar lavage (BAL). In addition, PET imaging data will be compared with disease severity based on pulmonary function testing.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Testing whether folate-based imaging using 68 Ga-EC2115 can be used to identify macrophages expressing the high affinity folate receptor (folate receptor beta).
Masking: Single (Outcomes Assessor)
Masking Description: The radiologist who evaluates the PET scan will be blinded to the to patient groups (COPD versus control)
Primary Purpose: Diagnostic
Official Title: Imaging Activated Macrophages in the Lungs
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Determine whether the PET signal in the lungs correlates with inflammation in bronchoalveolar lavage (BAL). [ Time Frame: 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 :
  1. Determine whether the PET signal in lungs can identify differences between patients with COPD and control subjects without COPD. [ Time Frame: 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).


Other Outcome Measures:
  1. Determine whether the PET signal in lungs correlates with COPD severity. [ Time Frame: 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 COPD patients and determine whether there is a correlation between PET signal and severity of COPD based on FEV1 (percent of predicted).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50-75 years of age
  • Non-smoker or former smoker (quit > 1 year ago)
  • 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)
  • Active smokers
  • Diagnosis of chronic lung disease other than COPD, i.e. - asthma, idiopathic pulmonary fibrosis
  • History of diagnosis or treatment of lung cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494114


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Endocyte
Investigators
Principal Investigator: Timothy S Blackwell, MD Vanderbilt University Medical Center

Responsible Party: Timothy Blackwell, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03494114     History of Changes
Other Study ID Numbers: 180071
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No