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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Recruiting
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
FMISO-PET Protocol
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 (AFTER SCREENING VISIT)

    • Abnormal 6 min walk test at screening
    • Abnormal PFT at screening with FVC ≤ 80% of predicted value and DLCO ≤ 75% of predicted value

Sites / Locations

  • Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with idiopathic pulmonary fibrosis

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

Lung SUVmean of 18F-FMISO measured in PET
Comparison in IPF patients and healthy volunteers

Secondary Outcome Measures

Full Information

First Posted
April 4, 2022
Last Updated
April 5, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT05331729
Brief Title
Evaluation of the Value of 18F-Fluoromisonidazole (18F-FMISO) Positron Emission Tomography Hypoxia Imaging in Idiopathic Pulmonary Fibrosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with idiopathic pulmonary fibrosis
Arm Type
Experimental
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
FMISO-PET Protocol
Intervention Description
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
Primary Outcome Measure Information:
Title
Lung SUVmean of 18F-FMISO measured in PET
Description
Comparison in IPF patients and healthy volunteers
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 (AFTER SCREENING VISIT) Abnormal 6 min walk test at screening Abnormal PFT at screening with FVC ≤ 80% of predicted value and DLCO ≤ 75% of predicted value
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume BELTRAMO
Phone
03 80 29 37 72
Email
guillaume.beltramo@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume BELTRAMO
Phone
03 80 29 37 72
Email
guillaume.beltramo@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

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

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