NCT04362644

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
13mo left

Started Dec 2020

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2020Jun 2027

First Submitted

Initial submission to the registry

March 2, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

December 8, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

6.5 years

First QC Date

March 2, 2020

Last Update Submit

July 9, 2025

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.

    screening to 48 hours post 2nd imaging visit.

Study Arms (1)

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

Interventions

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.

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

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Jonathan McConathy, MD, PhD

CONTACT

205-996-7115jmcconathy@uabmc.edu

April Riddle, BSRT

CONTACT

205-934-6504ariddle@uabmc.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics

Study Record Dates

First Submitted

March 2, 2020

First Posted

April 27, 2020

Study Start

December 8, 2020

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)