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NCT05365802 · ClinicalTrials.gov registry record · Early Phase 1
FAPI PET for Lung Fibrosis
A Early Phase 1 study of Interstitial Lung Disease and Pulmonary Fibrosis, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05365802: Recruiting Early Phase 1 study of Interstitial Lung Disease and Pulmonary Fibrosis, sponsored by University of California, Los Angeles.
NCT05365802 is a Early Phase 1 study of Interstitial Lung Disease and Pulmonary Fibrosis that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 30 participants, below the 566-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05365802, a Early Phase 1 study of Interstitial Lung Disease and Pulmonary Fibrosis, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective exploratory biodistribution study in patients with interstitial lung disease (ILD). The purpose of this research study is to determine where and to which degree the FAPI tracer (68Ga-FAPI-46) accumulates in normal and fibrotic lung tissues of patients with interstitial lung disease. The study will include patients with interstitial lung disease who have or will initiate a new ILD medication OR will undergo tissue biopsy or surgery of the lung. The study will include 30 patients, the upper limit for PET imaging studies conducted under the Radioactive Drug Research Committee (RDRC) purview. Participants will be injected with up to 7 mCi of 68-GaFAPi and will undergo one PET/CT scan and one High Resolution CT of the lungs. The study is sponsored by Ahmanson Translational Theranostic Division at UCLA.
Primary Outcome
To quantify diseased tissue and normal background organs, 68Ga-FAPI-46 positron emission tomography (PET) tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- DRUG 68Ga-FAPi-46
- PROCEDURE High Resolution Computed Tomography
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-11-16 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
What NCT05365802 shows while recruiting
NCT05365802 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 566-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (95% lower).
The record links to 7 conditions, with Interstitial Lung Disease appearing as the primary indexed condition, and to 4 interventions - of which Computed Tomography is the first listed.
NCT05365802 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05365802 about?
NCT05365802 is a clinical study titled "FAPI PET for Lung Fibrosis". This is a prospective exploratory biodistribution study in patients with interstitial lung disease (ILD). The purpose of this research study is to determine where and to which degree the FAPI tracer (68Ga-FAPI-46) accumulates in normal and fibrotic lung tissues of patients with interstitial lung di...
What is the current status of trial NCT05365802?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2021-11-16. Estimated completion is 2026-12.
What conditions does trial NCT05365802 study?
This clinical trial studies the following conditions: Interstitial Lung Disease, Pulmonary Fibrosis, Hypersensitivity Pneumonitis, Idiopathic Interstitial Pneumonias, Drug-Induced Pneumonitis.
What interventions are being tested in trial NCT05365802?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), 68Ga-FAPi-46 (DRUG), High Resolution Computed Tomography (PROCEDURE).
Who is sponsoring clinical trial NCT05365802?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05365802 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05365802's enrollment target sits among peer trials
30 27th of 36 higher than 7 of 36 other Interstitial Lung Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Interstitial Lung Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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