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NCT05365802Active, not recruitingEarly phase 1

FAPI PET for Lung Fibrosis

PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation.

Source: ClinicalTrials.gov · Last updated 20 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
30 (estimated)
First submitted
22 Apr 2022
Start date
16 Nov 2021
Primary completion date
1 Jul 2026
Lead sponsor
University of California, Los Angeles
NCT number
NCT05365802

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 30
  • From 16 Nov 2021 to the primary completion date, 1 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with active infectious lung disease

Other

  • Patient is pregnant or nursing
  • Patients not expected to comply with the protocol requirements, not able to understand or follow trial procedures

Who the study is looking for

  • Patients with ILD confirmed by CT at time of staging
  • Patients who have initiated or will initiate a new ILD medication with 3 months of enrollment OR Patients who are scheduled to undergo tissue biopsy or surgery of the lung
  • Patients are ≥ 18 years old at the time of the radiotracer administration
  • Patient can provide written informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UCLA / Jonsson Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.