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New treatment option for Idiopathic Pulmonary Fibrosis
Official title Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT04362644
What this study is testing
What is PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714?
PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714 is an investigational medicine, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- Age between 40-85 years old.
- A diagnosis of IPF that fulfills American Thoracic Society (ATS) / European Respiratory Society (ERS) 2018 consensus criteria within 5 years.
- Ability and willingness to give informed consent and adhere to study requirements.
- Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \>0.70.
- High or mixed affinity binder for TSPO ligands based on genotyping for single-nucleotide polymorphism (SNP)rs6971.
You likely can't join if
- Acute exacerbation of IPF within \<30 days
- Diagnosis of Diabetes Mellitus (Type 1 or Type 2).
- Diagnoses of current infection by clinical or microbial assessments.
- Treatment for \>14 days within the preceding month with \>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular...
- people with prior radiation therapy to the thorax.
- 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...
See the full eligibility criteria
- Age between 40-85 years old.
- A diagnosis of IPF that fulfills American Thoracic Society (ATS) / European Respiratory Society (ERS) 2018 consensus criteria within 5 years.
- Ability and willingness to give informed consent and adhere to study requirements.
- Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \>0.70.
- High or mixed affinity binder for TSPO ligands based on genotyping for single-nucleotide polymorphism (SNP)rs6971.
- Acute exacerbation of IPF within \<30 days
- Diagnosis of Diabetes Mellitus (Type 1 or Type 2).
- Diagnoses of current infection by clinical or microbial assessments.
- 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.
- people with prior radiation therapy to the thorax.
- 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.
- 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.
- people with known liver disease.
- Diagnosis of any active cancer with the exception of basal cell carcinoma of skin.
- Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.
- Active cigarette smoking or vaping
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.