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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
Must not have
Low affinity binder for TSPO ligands based on genotyping for SNP rs6971
Diagnosis of any active cancer with the exception of basal cell carcinoma of skin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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My genetic test shows I have a specific marker (SNP rs6971) for treatment response.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My genetics show low binding for specific brain markers.
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I have an active cancer diagnosis, except for skin cancer.
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I have a known liver disease.
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I have had radiation therapy to my chest area before.
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I have been diagnosed with diabetes (Type 1 or Type 2).
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I haven't taken high-dose steroids or immunosuppressants in the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,646 Previous Clinical Trials
2,342,374 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
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