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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
FAPI ILD Trial 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.Check my eligibility
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.See study design
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.
FAPI ILD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease
Secondary outcome measures
68Ga-FAPi-46 accumulation
68Ga-FAPi-46 and disease progression
68Ga-FAPi-46 biodistribution
FAPI ILD 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
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2210
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,537 Previous Clinical Trials
10,267,470 Total Patients Enrolled
Jeremie Calais, MDPrincipal InvestigatorClinical Research Director, Ahmanson Translational Theranostics
5 Previous Clinical Trials
152 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have started or plan to start taking medication for interstitial lung disease within the last 3 months OR you are scheduled to have a lung tissue biopsy or surgery.
Research Study Groups:
This trial has the following groups:- Group 1: 68Ga-FAPi-46
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment capacity for this research project?
"Affirmative. The clinicaltrial.gov listing for this experiment confirms that it is presently taking on participants, having been initially posted on November 16th 2021 and most recently updated on May 6th 2022. 30 individuals need to be recruited from a single site."
Answered by AI
Are there enrolment opportunities for this medical experimentation?
"Affirmative, the information on clinicaltrials.gov attests to this experiment's active recruitment phase. The investigation was initially posted on November 16th 2021 and underwent its last update May 6th 2022 with a target of 30 participants from 1 medical centre."
Answered by AI
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