Clinical Trials Logo
  1. Home
  2. Interstitial Lung Disease
  3. NCT05365802

FAPI PET for Lung Fibrosis — FAPI ILD  

Interstitial Lung Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. OUTLINE: 1. Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT and one High Resolution CT of the lungs 2. Patients will be followed until pathology is obtained during clinical care. (if undergoing surgery or biopsy) 3. Biodistribution results will be assessed comparing pathological findings and PET/CT results ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05365802
Study type Interventional
Source University of California, Los Angeles
Contact Hamzah Alam, BS
Phone 3102067372
Email HAlam@mednet.ucla.edu
Status Recruiting
Phase Early Phase 1
Start date November 16, 2021
Completion date December 2026
View Details
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04905693 - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis Phase 3
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Recruiting NCT05417776 - Collagen-targeted PET Imaging for Early Interstitial Lung Disease Phase 2
Not yet recruiting NCT04089826 - Long Term Oxygen Therapy in Patients With Interstitial Lung Disease
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT00883129 - Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II) Phase 2
Completed NCT00362739 - Blood Collection From Individuals With Lung Disease for Genetic Studies N/A
Recruiting NCT06133998 - Effects of Incentive Spirometry With and Without Aerobic Exercises in Interstitial Lung Disease N/A
Active, not recruiting NCT03485378 - Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease N/A
Recruiting NCT04098094 - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Recruiting NCT03400839 - Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases
Terminated NCT02633293 - An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE Phase 2/Phase 3
Enrolling by invitation NCT05001009 - Goals of Care Conversations Study N/A
Active, not recruiting NCT05068869 - Digital Outpatient Services N/A
Active, not recruiting NCT03727568 - Study Comparing Two Different Methods of Cryobiopsy in the Interstitial Lung Diseases N/A
Recruiting NCT06046547 - Integrating Palliative Care Education in Pulmonary Rehabilitation N/A
Completed NCT04946708 - Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients N/A
Recruiting NCT04139356 - The Effect of Spontaneous Respiration on Pulse-oximetry Measurements N/A
Recruiting NCT03726398 - CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH Phase 2/Phase 3
Active, not recruiting NCT03295279 - WTC Chest CT Imaging Archive