NCT04362644 Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
| NCT ID | NCT04362644 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2020-12-08 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2020-12-08 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04362644 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04362644 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04362644 currently recruiting?
Yes, NCT04362644 is actively recruiting participants. Contact the research team at jmcconathy@uabmc.edu for enrollment information.
Where is the NCT04362644 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT04362644 clinical trial?
NCT04362644 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 10 participants.