NCT05331729CompletedPhase 1
Evaluation of the Value of 18F-Fluoromisonidazole (18F-FMISO) Positron Emission Tomography Hypoxia Imaging in Idiopathic Pulmonary Fibrosis
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
Source: ClinicalTrials.gov · Last updated 4 Mar 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 4 Apr 2022
- Start date
- 20 Mar 2023
- Primary completion date
- 20 Feb 2025
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT05331729
- EU CT number
- 2024-515303-19-00
- EudraCT number
- 2021-005454-28
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 20 Mar 2023 to the primary completion date, 20 Feb 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient requiring long-term oxygen therapy (excluding ambulatory oxygen therapy alone)
Other illness
- 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.)
Lab values
- 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)
Other
- Person who is not covered by national health insurance
- Exacerbation of IPF during treatment
- Active smoking
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.