Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 40 to 85

Using imaging to understand lung inflammation in pulmonary fibrosis

Official title: Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

Run by University of Alabama at Birmingham · NCT04362644 · Data updated 2026-11-12

This study is testing new imaging techniques to see if they can help doctors better understand lung inflammation in people with idiopathic pulmonary fibrosis.

Quick facts

PhasePhase 1
Study typeInterventional
Ages40 Years to 85 Years
SexAll
Enrollment10 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Drugs / interventionsradiation, prednisone
Locations1 site (Birmingham, Alabama)
StatusRecruiting
StartedDecember 8, 2020
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedAugust 12, 2026
Trial IDNCT04362644 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 40-85 with a recent diagnosis of idiopathic pulmonary fibrosis meeting specific clinical criteria.

Probably not a fit

Patients experiencing acute exacerbations of IPF or those with certain comorbidities, such as diabetes or recent infections, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of molecular imaging probes, specifically fluorine-18 Fluorodeoxyglucose and fluorine-18 Displacement Per Atom, in detecting lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). By utilizing positron emission tomography and computed tomography (PET/CT), the study seeks to provide insights into the heterogeneity of IPF, which may inform future treatment strategies. Participants will undergo imaging to assess their condition, contributing to a better understanding of IPF.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and treatment approaches for patients with idiopathic pulmonary fibrosis.

How similar studies have gone: While the use of imaging in pulmonary fibrosis is explored, this specific approach using these particular probes is relatively novel.

Who can join: the full rules

Show full 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

Where it's running

  • The University of Alabama at Birmingham
    Birmingham, Alabama, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • New IPF drug ORJ-001 tested in adults with IPF

    A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.

    Recruiting at 2 sites Phase 2 Oorja Bio, Inc. · Doral, Florida and 1 other locations · NCT07869147

  • Nalbuphine ER for IPF-related chronic cough

    This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.

    Recruiting at 4 sites Phase 3 Trevi Therapeutics · Wilmington, Delaware and 3 other locations · NCT07868419

  • Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

    This observational study tests how fast patients with IPF or PPF can inhale through dry powder inhalers with different resistances.

    Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07820254

  • Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs

    This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.

    Recruiting Istituto Clinico Humanitas · Rozzano, Italy · NCT07790614

  • Rentosertib by mouth for people with idiopathic pulmonary fibrosis

    This is a randomized, placebo-controlled test to see if Rentosertib helps adults with idiopathic pulmonary fibrosis when taken as a pill.

    Recruiting at 12 sites Phase 3 InSilico Medicine Hong Kong Limited · Hefei, Anhui and 46 other locations · NCT07687459

  • Inhaled nintedanib powder for IPF in adults

    This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.

    Recruiting Phase 2 Mannkind Corporation · Windsor, Ontario · NCT07679893

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.