FAPI PET for Lung Fibrosis (FAPI ILD)
-
- STATUS
- Recruiting
-
- End date
- Dec 30, 2023
-
- participants needed
- 30
-
- sponsor
- University of California, Los Angeles
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 with fibrotic lesions who are scheduled to undergo lung biopsy or transplantation.
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.
The study is sponsored by Ahmanson Translational Theranostic Division at UCLA.
Description
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 who are scheduled for lung biopsy or transplantation.
The biodistribution will be validated by histopathology and immunohistochemistry from obtained lung tissue.
- OUTLINE
-
- Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT
- Patients will be followed until pathology is obtained during clinical care.
- Biodistribution results will be assessed comparing pathological findings and PET/CT results
Details
| Condition | Interstitial Lung Disease, Idiopathic Interstitial Pneumonias, Drug-Induced Pneumonitis, Hypersensitivity Pneumonitis, Radiation Pneumonitis, Pneumoconiosis, Pulmonary Fibrosis |
|---|---|
| Treatment | computed tomography, positron emission tomography, 68Ga-FAPI-46 |
| Clinical Study Identifier | NCT05365802 |
| Sponsor | University of California, Los Angeles |
| Last Modified on | 30 May 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer