UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Location status: Recruiting
NCT Number: NCT05365802
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Los Angeles, California, 90095, United States
Location status: Recruiting
ILD is a group of respiratory diseases that affect the interstitium of the lungs. A major problem is the highly variable course of fibrosing ILD: some patients remain stable without treatment, and others progress rapidly despite pharmacotherapy.
Novel diagnostic approaches for risk stratification with more accurate prediction of the course of fibrosing ILD could potentially improve prognostication and ultimately lead to better survival in these patients.
Persistent activation and local accumulation of myofibroblasts is a common feature of fibrotic diseases. FAP is a promising target for molecular imaging of fibroblast activation and detection of sites of active tissue remodeling.
Small molecule inhibitors of FAP have been labeled with positron-emitting isotopes for PET imaging. 68Ga-FAPi-46 can serve as diagnostic biomarker in ILD.
In this study, the investigators will evaluate the 68Ga-FAPi-46 biodistribution in patients with ILD and observe the correlation of FAP expression and FAPi radiopharmaceutical uptake.
The primary objective of this study is to evaluate the biodistribution of the new FAP-targeted PET tracer, 68Ga-FAPi- 46, in patients with ILD.
OUTLINE:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiopharmaceutical will be administered via IV
Other names: Gallium-68-FAPi-46
As part of PET/CT scan
Other names: CT scan
As part of PET/CT scan
Other names: PET scan
Will be conducted immediately after FAPI PET/CT
Time frame: 60 minutes following injection
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)).
Time frame: Up to 2 years
To evaluate the degree of 68Ga-FAPi-46 accumulation observed by PET imaging as opposed to the amount of FAP expression in obtained lung tissue, when available. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.
Time frame: Up to 2 years
To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with disease progression under ILD therapies.
Time frame: Up to 2 years
To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with HR CT quantitative parameters
Contact information is provided by the study sponsor or research team.
Contreras M Maria, BS
CONTACT
Stephanie Lira
CONTACT
University of California, Los Angeles
Other
PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation.
Acronym: FAPI ILD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05392881
Alveolitis, Extrinsic Allergic, Fibrosis
Kansas City, Kansas, United States
View Trial DetailsNCT06329401
Alveolitis, Extrinsic Allergic, Fibrosis
Birmingham, Alabama, United States
View Trial DetailsNCT04896138
Alveolitis, Extrinsic Allergic, Connective Tissue Diseases
Charlottesville, Virginia, United States
View Trial DetailsNCT06702228
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Connective Tissue Diseases
Dublin, Ireland
View Trial Details