Skip to main content
OpenTrials
Completed

NCT Number: NCT05331729

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For all patients (IPF and healthy volunteers) :

  • Person who has given written consent
  • Age ≥ 50 years
  • Absence of disease, comorbidity, or treatment that may interfere with the evaluation of the study objective, as decided by the investigator

For patients with IPF only:

  • Diagnosis of IPF according to the criteria of the current international recommendations (ATS/ERS/JRS/ALAT of 2011) and validated in a multi-disciplinary meeting in a Competence or Reference Center
  • Patients who have had a high-resolution thoracic CT scan less than 1 month previously as part of the management of their disease
  • Patients who have had a PFT less than 1 month previously as part of the management of their disease

For healthy volunteers only:

  • Absence of functional respiratory signs - absence of dyspnea on exertion and at rest and absence of chronic cough.
  • Normal clinical examination with no crackles on pulmonary auscultation
  • No personal history of chronic hypoxemic respiratory disease

Exclusion criteria

  • Person who is not covered by national health insurance
  • Cancer or history of cancer in the past 5 years (except basal cell skin cancer)
  • Chronic lung disease other than IPF or a history incompatible with the diagnosis of idiopathic pulmonary fibrosis (thoracic radiotherapy, pneumotoxic chemotherapy, etc.)
  • Exacerbation of IPF during treatment
  • Active smoking
  • Patient requiring long-term oxygen therapy (excluding ambulatory oxygen therapy alone)
  • Contraindication to PET or CT scan or presence of a condition disturbing the interpretation :
  • known allergy to 18F-FMISO
  • pregnancy or breastfeeding
  • claustrophobia
  • uncontrolled type I/II diabetes (HbA1c >7%)
  • surgical intervention in the previous month
  • Radiotherapy session in the previous 3 months
  • concomitant granulomatous condition (sarcoidosis type) or pulmonary inflammation
  • Moderate or severe renal insufficiency (GFR < 70 ml/min/1.73 m²)
  • Person under legal protection (curatorship, guardianship)
  • Adult unable to express consent
  • SECONDARY EXCLUSION CRITERIA only for healthy volunteers
  • Abnormal 6 min walk test at screening
  • Abnormal PFT at screening with FVC ≤ 80% of predicted value and DLCO ≤ 75% of predicted value

Treatment and study plan

FMISO-PET Protocol

Radiation
  • 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

Primary outcomes

  1. Lung SUVmean of 18F-FMISO measured in PET

    Time frame: At baseline

    Comparison in IPF patients and healthy volunteers

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: FIPOXY

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2022
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.