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Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

Study Purpose

The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose ([18F] FDG) and fluorine-18 Displacement Per Atom ([18F]DPA-714) using positron emission tomography and computed tomography (PET/CT) will show lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study may help physicians and researchers better understand how best to treat patients with IPF in the future.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age between 40-85 years old. 2. A diagnosis of IPF that fulfills American Thoracic Society (ATS) / European Respiratory Society (ERS) 2018 consensus criteria within 5 years. 3. Ability and willingness to give informed consent and adhere to study requirements. 4. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) >0.70. 5. High or mixed affinity binder for TSPO ligands based on genotyping for single-nucleotide polymorphism (SNP)rs6971.

Exclusion Criteria:

1. Acute exacerbation of IPF within <30 days. 2. Diagnosis of Diabetes Mellitus (Type 1 or Type 2). 3. Diagnoses of current infection by clinical or microbial assessments. 4. Treatment for >14 days within the preceding month with >20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immunosuppressant. 5. Subjects with prior radiation therapy to the thorax. 6. Women who are pregnant, or who are breastfeeding. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration. 7. Severe cardiovascular disease, defined as any of the following within the preceding 12 weeks: acute myocardial infarction or unstable angina, a coronary revascularization procedure, or stroke. 8. Subjects with known liver disease. 9. Diagnosis of any active cancer with the exception of basal cell carcinoma of skin. 10. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971. 11. Active cigarette smoking or vaping

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04362644
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Alabama at Birmingham
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Arms & Interventions

Arms

Experimental: PET/CT using PET ligands [18F]FDG and [18F]DPA-714

Interventions

Drug: - PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714

Study participants will undergo PET/CT with the glucose analogue [F-18]FDG and the translocator protein (TSPO) ligand [F-18]DPA-714 in two separate imaging sessions.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

The University of Alabama at Birmingham

Birmingham, Alabama, 35249

Site Contact

April Riddle, BSRT

ariddle@uabmc.edu

205-934-6504