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Radiopharmaceutical

FAPI PET for Lung Fibrosis (FAPI ILD Trial)

Phase < 1
Recruiting
Led By Jeremie Calais, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at how well a new imaging agent called 68-GaFAPi works in people with interstitial lung disease. The study will follow 30 patients and look at where and how much the agent accumulates in normal and diseased lung tissue.

Who is the study for?
This trial is for adults over 18 with interstitial lung disease (ILD), confirmed by a CT scan within the last 3 months. Participants must be starting new ILD medication soon or scheduled for lung biopsy or surgery. Pregnant or nursing individuals, those with active infectious lung disease, and anyone unable to follow the study plan are excluded.
What is being tested?
The study tests how a tracer called 68Ga-FAPI-46 distributes in normal versus fibrotic lung tissues in ILD patients. Each participant will receive an injection of this tracer followed by one PET/CT scan and one high-resolution CT of their lungs to track the tracer's accumulation.
What are the potential side effects?
Potential side effects from the FAPI PET scan may include discomfort at the injection site, allergic reactions to the tracer, and exposure to radiation from both scans which carries a small risk of cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease
Secondary study objectives
68Ga-FAPi-46 accumulation
68Ga-FAPi-46 and disease progression
68Ga-FAPi-46 biodistribution

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: 68Ga-FAPi-46Experimental Treatment4 Interventions
Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Resolution Computed Tomography
2021
N/A
~40
Computed Tomography
2017
Completed Phase 2
~2740
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,159 Total Patients Enrolled
Jeremie Calais, MDPrincipal InvestigatorClinical Research Director, Ahmanson Translational Theranostics
5 Previous Clinical Trials
152 Total Patients Enrolled

Media Library

68Ga-FAPi-46 (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT05365802 — Phase < 1
Interstitial Lung Disease Research Study Groups: 68Ga-FAPi-46
Interstitial Lung Disease Clinical Trial 2023: 68Ga-FAPi-46 Highlights & Side Effects. Trial Name: NCT05365802 — Phase < 1
68Ga-FAPi-46 (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05365802 — Phase < 1
~10 spots leftby May 2026
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