Evolution of Lung 18FDG Uptake in Patients With Idiopathic Pulmonary Fibrosis and Receiving Pirfenidone

NCT03692481 | Unknown

• 1 other identifier: P180301J
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic pulmonary fibrosis (IPF) is a rare and fatal lung disease characterized by unpredictable changes with variable kinetics of progression. Changes in pulmonary function (FVC, DLCO) assessed at the time of diagnosis, or decline in pulmonary function within 12 months after diagnosis, are the best predictors of survival, but poorly predicted disease activity and evolution. 18FDG positron emission tomography (18FDG PETscan) provides the ability to quantify cell metabolism in vivo and non-invasively using a labeled non-metabolizable substrate. Several parameters can be measured in an automated and reproducible way, such as the mean fixation intensity (SUV mean), the maximum fixation intensity (SUV max), the hyperfixing volume measurement (MLV) or the glycolytic activity measurement tissue or TLG (total lesions glycolysis). Several studies have demonstrated an increase of glycolytic activity in lung fibroblast from IPF patient. In a recent study, the investigators demonstrated a strong correlation between the lung uptake parameters and the lung function tests results (LFTs) and prognostic score GAP. In addition, MLV and TLG were factors prognostic and independently associated with progression-free survival at 12 months. In a preliminary study, the investigators studied the change of these parameters in twelve patients treated with pirfenidone for IPF who performed an 18FDG PETscan before the initiation of treatment and about twelve weeks later. A mean decrease of 30% in TLG value between the two evaluations was observed. These preliminary data suggest that pirfenidone influences lung metabolism in patients with IPF. The investigators aim to conduct a prospective study to confirm and refine the preliminary data.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis (IPF); 18FDG uptake; prognosis

Outcome Measures

Primary Outcomes (1)

• Changes of 18FDG lung uptake (TLG variation) in patients with IPF 12 weeks after the initiation of pirfenidone

  To describe the changes of 18FDG lung uptake assessed by TLG variation in patients with IPF 12 weeks after the initiation of pirfenidone

  12 weeks

Secondary Outcomes (8)

• Change of 18FDG lung uptake in patients with IPF 12 weeks after the initiation of pirfenidone : variation of SUVmean between baseline and after 12 weeks of treatment

  12 weeks

• Change of 18FDG lung uptake in patients with IPF 12 weeks after the initiation of pirfenidone : variation of SUVmax between baseline and after 12 weeks of treatment

  12 weeks

• Change of 18FDG lung uptake in patients with IPF 12 weeks after the initiation of pirfenidone : variation of MLV between baseline and after 12 weeks of treatment

  12 weeks

• Variation of the PET parameter SUVmean between baseline and 12 weeks and FVC at 12, 24, 36 and 48 weeks

  48 weeks

• Variation of the PET parameter SUVmax between baseline and 12 weeks and FVC at 12, 24, 36 and 48 weeks

  48 weeks

Study Arms (1)

18FDG-PET scan

EXPERIMENTAL

18FDG PET scan will be performed in each patient before initiation of pirfenidone and after 12 weeks of treatment

Radiation: 18FDG-PET scan

Interventions

18FDG-PET scan RADIATION

18FDG PET scan will be performed in each patient before initiation of pirfenidone and after 12 weeks of treatment

18FDG-PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IPF, diagnosed accordingly to ATS/ERS/JRS/ALAT international guidelines
• FVC≥50% and DLCO≥30%
• Decision to initiate a treatment with pirfenidone
• Affiliation to the French social security system

You may not qualify if:

• Will be non-eligible in this study any patient:
• with an age lower than 18 years
• with a life expectancy lower than 12 months as assessed by the investigator
• taking an anti-fibrotic treatment (pirfenidone, nintedanib or any experimental molecule) in the previous three months
• treated by corticosteroid therapy (daily dose \> 10 mg, prednisone equivalent)
• with neoplasia localized in thorax
• with contraindication to pirfenidone according to the French Summary of Product Characteristics : hypersensitivity to the active substance or to any of the excipients, past history of angioedema with pirfenidone, concomitant treatment with fluvoxamine, severe or terminal hepatic insufficiency, severe renal insufficiency (CrCl \<30ml / min) or end-stage requiring dialysis
• with a positive pregnancy test or currently breastfeeding
• with contraindication to performing a 18FDG PETscan, ie 18FDG hypersensitivity
• with emphysema extension \>15% on HRCT according to Cottin et al (16).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Pneumologie A Centre constitutif de référence des maladies pulmonaires rares Hôpital Bichat Claude Bernard

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bruno Crestani, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Crestani, MD, PhD

CONTACT

00 33 1 40 25 68 00; bruno.crestani@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: October 2, 2018
• Study Start: February 4, 2020
• Primary Completion: February 1, 2023
• Study Completion: April 1, 2024
• Last Updated: October 4, 2022

Record last verified: 2022-09

Locations

FR (1)