Idiopathic Pulmonary FibrosisPhase 1NCT04362644
Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
A Phase 1 study testing PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714 in people with Idiopathic Pulmonary Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Subjects 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.
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- 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.
- Subjects 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
April Riddle, BSRT, 205-934-6504, ariddle@uabmc.edu
About this study
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT using PET ligands [18F]FDG and [18F]DPA-714 | Experimental | Not described Receives: Drug: PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.
Measured: screening to 48 hours post 2nd imaging visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start8 Dec 2020
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepak Prabataram Kalbi, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362644
- Sponsor's protocol ID
- IRB-300004249 R20-010
- Other IDs
- 3109239
- Status last verified
- Aug 2026
- First submitted
- 2 Mar 2020
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT04362644
- Acronym / sponsor ID
- IRB-300004249 R20-010
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT using PET ligands [18F]FDG and [18F]DPA-714 | Experimental | Drug: PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
- Subjects with prior radiation therapy to the thorax.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714Study 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. | Drug | PET/CT using PET ligands [18F]FDG and [18F]DPA-714 |
Primary outcome
Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.
Time frame: screening to 48 hours post 2nd imaging visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714 in people with Idiopathic Pulmonary Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan McConathy, MD, PhD (205-996-7115, jmcconathy@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests. (time frame: screening to 48 hours post 2nd imaging visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.