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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	50 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05331729
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Hospitalier Universitaire Dijon
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Arms & Interventions

Arms

Experimental: Patients with idiopathic pulmonary fibrosis

Active Comparator: Healthy volunteers

Interventions

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

Contact a Trial Team

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