Molecular Imaging Probes to Inform Heterogeneity in Idiop... | NCT04362644

Studies
Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

NCT04362644

Sponsor

University of Alabama at Birmingham

Status

Recruiting

Last Update Posted

Jun 2, 2026Actual

Enrollment

10Estimated

Phase

Phase 1

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
3109239	Other Grant/Funding Number	UAB Pulmonology

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 2020Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Mar 2, 2020

First Submission Date that Met QC Criteria

Apr 23, 2020

First Posted Date

Apr 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2026

Last Update Posted Date

Jun 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714	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.

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jonathan McConathy, MD, PhD	Contact	205-996-7115		jmcconathy@uabmc.edu
April Riddle, BSRT	Contact	205-934-6504		ariddle@uabmc.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Alabama at Birmingham	Recruiting	Birmingham	Alabama	35249	United States

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases