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

NCT05331729 | Completed Phase 1

• 1 other identifier: BELTRAMO_APJ_2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Lung SUVmean of 18F-FMISO measured in PET

  Comparison in IPF patients and healthy volunteers

  At baseline

Study Arms (2)

Patients with idiopathic pulmonary fibrosis

EXPERIMENTAL

Radiation: FMISO-PET Protocol

Healthy volunteers

ACTIVE COMPARATOR

Radiation: FMISO-PET Protocol

Interventions

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

Healthy volunteers; Patients with idiopathic pulmonary fibrosis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 18, 2022
• Study Start: March 20, 2023
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)