Status:
COMPLETED
Evaluation of the Value of 18F-Fluoromisonidazole (18F-FMISO) Positron Emission Tomography Hypoxia Imaging in Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
50+ years
Phase:
PHASE1
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05331729
Start Date
March 20 2023
End Date
February 20 2025
Last Update
March 4 2025
Active Locations (1)
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1
Chu Dijon Bourgogne
Dijon, France, 21000