68Ga-FAPi-46 for Radiation Pneumonitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, CA
Radiation Pneumonitis+12 More
68Ga-FAPi-46 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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 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.

Eligible Conditions

  • Radiation Pneumonitis
  • Pulmonary Fibrosis
  • Bagassosis
  • Lung Diseases, Interstitial
  • Alveolitis, Extrinsic Allergic
  • Idiopathic Interstitial Pneumonias
  • Drug-Induced Pneumonitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 2 years

60 minutes following injection
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease
Up to 2 years
68Ga-FAPi-46 accumulation

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

68Ga-FAPi-46
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: 68Ga-FAPi-46 · No Placebo Group · Phase < 1

68Ga-FAPi-46Experimental Group · 3 Interventions: 68Ga-FAPi-46, Computed Tomography, Positron Emission Tomography · Intervention Types: Drug, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3460
Positron Emission Tomography
2019
Completed Phase 2
~3050

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, CA
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
2016First Recorded Clinical Trial
1 TrialsResearching Radiation Pneumonitis
60 CompletedClinical Trials

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,381 Previous Clinical Trials
6,521,117 Total Patients Enrolled
Jeremie Calais, MDPrincipal InvestigatorClinical Research Director, Ahmanson Translational Theranostics
4 Previous Clinical Trials
192 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A diagnosis of idiopathic interstitial pneumonia has been made.
A disease that is associated with the immune system.
You have a history of a drug-induced pneumonitis.
You have a history of hypersensitivity pneumonitis.
You have pneumoconiosis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.