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Early recognition of progressive lung fibrosis in systemic rheumatic diseases: a characterization of the pulmonary environment through extracellular vesicles, advanced and functional imaging

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516304-42-00
Acronym
COOPERATION 2.0
Enrollment
35
Registered
2024-11-11
Start date
2025-05-30
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with connective tissue diseases at high risk of interstial lung disease

Brief summary

The following measures will be evaluated in FAPI PET-CT: pattern and distribution of FAPI uptake, mean and maximum Standardized Uptake Value (SUV mean and SUV max) of pulmonary fibrotic lesions, fibrotic active volume (FAV), total fibrosis (calculated as the product of SUV mean and the fibrotic active volume), uptake ratio between fibrotic and healthy lung tissue. These measures will be compared between CTD-ILD patients with and without progressive phenotypes at the 12-month follow-up

Detailed description

AI-collected measures of lung anatomy (including lung texture, airway, and vascular measures) and serum EV single-protein quantity and RNA expression measures, Exploratory endpoint: BALF EV single-protein quantity and RNA expression measures

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The following measures will be evaluated in FAPI PET-CT: pattern and distribution of FAPI uptake, mean and maximum Standardized Uptake Value (SUV mean and SUV max) of pulmonary fibrotic lesions, fibrotic active volume (FAV), total fibrosis (calculated as the product of SUV mean and the fibrotic active volume), uptake ratio between fibrotic and healthy lung tissue. These measures will be compared between CTD-ILD patients with and without progressive phenotypes at the 12-month follow-up

Secondary

MeasureTime frame
AI-collected measures of lung anatomy (including lung texture, airway, and vascular measures) and serum EV single-protein quantity and RNA expression measures, Exploratory endpoint: BALF EV single-protein quantity and RNA expression measures

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026