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PET/CT Imaging for Idiopathic Pulmonary Fibrosis
Phase 1
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 40-85 years old
High or mixed affinity binder for TSPO ligands based on genotyping for single-nucleotide polymorphism (SNP)rs6971
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening to 48 hours post 2nd imaging visit.
Awards & highlights
Study Summary
This trial is testing if two different imaging techniques can show evidence of lung inflammation and fibrosis in patients with idiopathic pulmonary fibrosis. The results may help guide future treatment decisions for patients with this condition.
Who is the study for?
This trial is for adults aged 40-85 with a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) according to specific criteria, who can consent and follow study procedures. They must have certain lung function levels and genetic markers. Excluded are those with severe heart disease, liver disease, recent cancer (except skin), diabetes, recent IPF exacerbation or infection, high-dose steroid or immunosuppressant use in the last month, and current smokers/vapers.Check my eligibility
What is being tested?
The trial tests if PET/CT scans using two imaging agents ([18F]FDG and [18F]DPA-714) can effectively show inflammation and fibrosis in the lungs of IPF patients. This could improve understanding of IPF's variability among patients and inform future treatment strategies.See study design
What are the potential side effects?
While not explicitly listed for this imaging study, potential side effects may include allergic reactions to tracers used in PET/CT scans, discomfort from injection site for tracers, exposure to radiation during scanning which carries a small risk of cancer over time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 85 years old.
Select...
My genetic test shows I have a specific marker (SNP rs6971) for treatment response.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening to 48 hours post 2nd imaging visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening to 48 hours post 2nd imaging visit.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PET/CT using PET ligands [18F]FDG and [18F]DPA-714Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,344 Total Patients Enrolled
6 Trials studying Idiopathic Pulmonary Fibrosis
1,192 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with IPF based on ATS/ERS criteria within the last 5 years.I am between 40 and 85 years old.Your breathing test shows a specific ratio of air you can force out in one second to the total amount you can force out.My genetics show low binding for specific brain markers.I have not had a heart attack, unstable angina, heart surgery, or stroke in the last 3 months.My genetic test shows I have a specific marker (SNP rs6971) for treatment response.I have an active cancer diagnosis, except for skin cancer.I have a known liver disease.I am not pregnant or breastfeeding.I have had radiation therapy to my chest area before.I have been diagnosed with diabetes (Type 1 or Type 2).My lung condition has worsened in the last 30 days.You currently have an infection based on tests done by the doctor.I haven't taken high-dose steroids or immunosuppressants in the last month.You currently smoke cigarettes or use e-cigarettes.
Research Study Groups:
This trial has the following groups:- Group 1: PET/CT using PET ligands [18F]FDG and [18F]DPA-714
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT04362644 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who has been deemed eligible to take part in this research?
"This research seeks 10 suitable individuals suffering from usual interstitial pneumonia aged between 40 and 85 to participate in the trial. The following criteria must be fulfilled: Age range of 40-85 years old, FEV1/FVC ratio greater than 0.70.."
Answered by AI
What potential hazards could patients face when undergoing PET/CT with [F-18]FDG and [F-18]DPA-714?
"With limited data to support their safety and efficacy, PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714 have been given a rating of 1."
Answered by AI
Are individuals younger than 50 years of age allowed to join this experiment?
"Consistent with this clinical trial's inclusion criteria, the lower limit for enrollment is 40 years old and the upper limit 85."
Answered by AI
Are there currently any open slots in this research trial?
"As recorded on clinicaltrials.gov, recruitment is still underway for this research endeavour that was first announced on December 8th 2020 and has been modified as recently as June 7th 2022."
Answered by AI
What is the sample size for this clinical research project?
"Affirmative. The relevant information available on clinicaltrials.gov validates that this research is still searching for volunteers, having first been put up in December 8th 2020 and updated last June 7th 2022. This study requires 10 participants to be enrolled at one specific site."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
The University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
i have tried nintedanib but condition getting worse.
PatientReceived 2+ prior treatments
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