Imaging Activated Macrophages in the Lungs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-29

Study Completion Date

2021-01-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Advanced Imaging for Pulmonary Fibrosis

NCT06532071

Pulmonary Fibrosis

RECRUITING PHASE2

68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis

NCT02511197

Pulmonary Fibrosis, Unspecified

UNKNOWN EARLY_PHASE1

PET-DECT for Staging and Imaged Based Radiotherapy Planning in Lung Cancer

NCT03146117

PET CT

TERMINATED

From Inflammation to Remodelling Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19

NCT06911476

PASC Post Acute Sequelae of COVID 19 Long COVID Long Covid-19 +6 more

NOT_YET_RECRUITING

68Gallium-FAPI PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases

NCT06275477

Inflammatory Disease

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

The radiologist who evaluates the PET scan will be blinded to the to patient groups (COPD versus control)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Ga-EC2115

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Ga-EC2115

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ga-EC2115

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes