Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

NCT ID: NCT04362644

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-08

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Pulmonary Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jonathan E McConathy

M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jonathan McConathy, MD, PhD

Role: CONTACT

205-996-7115

April Riddle, BSRT

Role: CONTACT

205-934-6504

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

April Riddle, BSRT

Role: primary

205-934-6504

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3109239

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R20-010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Genentech Xenon MRI Idiopathic Pulmonary Fibrosis
NCT04071769 ACTIVE_NOT_RECRUITING PHASE2
Detection of Early Idiopathic Pulmonary Fibrosis
NCT03457935 ACTIVE_NOT_RECRUITING
P4O2 ILD Extension
NCT06644144 RECRUITING
Advancing Prevention of Pulmonary Fibrosis
NCT04564183 ACTIVE_NOT_RECRUITING