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

NCT05331729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2025-02-20
Completion
2025-02-20

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05331729 on ClinicalTrials.gov