NCT05331729

Evaluation of the Value of 18F-Fluoromisonidazole (18F-FMISO) Positron Emission Tomography Hypoxia Imaging in Idiopathic Pulmonary Fibrosis

Evaluation of the Value of 18F-Fluoromisonidazole (18F-FMISO) Positron Emission Tomography Hypoxia Imaging in Idiopathic Pulmonary Fibrosis - a Non-randomized Proof-of-concept Study Comparing Patients with Idiopathic Pulmonary Fibrosis and Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

Idiopathic pulmonary fibrosis (IPF) is a rare, chronic, lethal disease of unknown etiology and with a variable course. There is currently no test in routine care that can assess both the anatomical and functional damage of the disease at an early stage. This is the first human study in IPF to evaluate the value of a non-invasive tracer, 18F-fluoromisonidazole (18F-FMISO), targeting hypoxia in IPF patients. This is a Phase I, proof-of-concept, single-center, open-label, parallel group study. It will include 2 groups: * 1 group of 10 IPF patients * 1 group of 10 healthy volunteers matched to IPF patients for age and gender

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
RADIATION	FMISO-PET Protocol	* injection of 18F-FMISO * Monitoring for 2 h * PET scan (30 min) 2h post injection * Monitoring for 2h * PET (30min) 4h post injection * Discharge of the subject with appropriate recommendations after a PET/CT

Timeline

• Start date: 2023-03-20
• Primary completion: 2025-02-20
• Completion: 2025-02-20
• First posted: 2022-04-18
• Last updated: 2025-03-04

Locations

1 site across 1 country: France