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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with idiopathic pulmonary fibrosis | Experimental |
| |
| Healthy volunteers | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMISO-PET Protocol | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lung SUVmean of 18F-FMISO measured in PET | Comparison in IPF patients and healthy volunteers | At baseline |
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Inclusion Criteria:
For all patients (IPF and healthy volunteers) :
For patients with IPF only:
For healthy volunteers only:
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 :
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Dijon Bourgogne | Dijon | 21000 | France |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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