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

Idiopathic Pulmonary Fibrosis Clinical Trial

— FIPOXY  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05331729
• Other study ID #: BELTRAMO_APJ_2019
• Status: Recruiting
• Phase: Phase 1
• Start date: March 20, 2023
• Est. completion date: May 2026

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Guillaume BELTRAMO
• Phone: 03 80 29 37 72
• Email: guillaume.beltramo[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Hypoxia
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung SUVmean of 18F-FMISO measured in PET	Comparison in IPF patients and healthy volunteers	At baseline