NCT07493187

Brief Summary

Non-neoplastic pulmonary proliferative diseases are characterized by a complex interaction between proliferating lung cells and a variety of resident and infiltrating host cells, secreted factors, and extracellular matrix proteins, collectively referred to as the microenvironment. Idiopathic pulmonary fibrosis (IPF) refers to a specific condition characterized by chronic interstitial pneumonia and fibrosis of unknown cause, for which there are still no effective treatments. According to the current pathogenetic perspective, the aberrant proliferative events in IPF resemble those occurring during malignant transformation in tumors. Growing evidence supports the neoplasm-like molecular profile of IPF, and this fascinating hypothesis is beginning to be exploited for therapeutic purposes. Tyrosine kinase receptors (RTKs) are known to be major players in the onset and progression of cancer. Among these, the proto-oncogene MET is a key regulator of the invasive growth program. MET encodes the TK receptor for the "dispersion factor" or hepatocyte growth factor (HGF), a sensor of adverse microenvironmental conditions (e.g., hypoxia and ionizing radiation) that drives cellular invasion and metastasis through transcriptional activation of the "invasive growth signature." We and others have previously reported that both myofibroblasts and epithelial cells in fibroblastic foci (FFs) in IPF express MET in its activated form (MACTIF study). MRI technology will help identify hypoxic areas and thus those patients who may potentially benefit from anti-MET therapeutic lockade. Magnetic resonance imaging (MRI) has an incredible ability to distinguish between different tissue components. Advanced techniques such as diffusion, mapping, ventilation, and perfusion allow for even more precise tissue characterization. For example, perfusion imaging can quantify the spatial distribution and extent of oxygen delivery to tissues in vivo and is therefore the best method for assessing vascular oxygenation. On the other hand, ventilation imaging allows for a quantitative analysis of pulmonary physiology, in vivo pulmonary ventilation, and oxygen sensitivity; in this way, the "alveolar" aspect of the oxygenation process will be explored. Since the introduction of MRI imaging for the evaluation of lung diseases, various limitations, primarily related to the relatively low proton density of the lung parenchyma and respiratory motion artifacts, have hindered the clinical application of this technique. In recent decades, technical advances have addressed many of these limitations. MRI could enable the assessment of hypoxic areas in IPF and thus lead to the identification of patients at risk of disease progression and validate MET as a new therapeutic target. No attempts have yet been reported in the literature regarding the study of pulmonary microenvironment characteristics using advanced MRI imaging.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2020

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

5.3 years

First QC Date

March 19, 2026

Last Update Submit

March 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of the ability of advanced magnetic resonance imaging techniques to assess tissue oxygenation and local hypoxia in early interstitial pulmonary fibrosis (proliferative stage)

    up to 36 months

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with idiopathic pulmonary fibrosis (IPF) in the early stages

You may qualify if:

  • Clinical and radiological diagnosis of early-stage IPF

You may not qualify if:

  • Absolute contraindications to bronchoalveolar lavage or magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start

December 28, 2020

Primary Completion

April 28, 2026

Study Completion

April 28, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations