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Clinical Utility of LIBS Multi-Element Imaging and the IFF Algorithm in Chronic Lung Diseases

Evaluation of the Clinical Utility of LIBS Multi-Element Imaging and the IFF Algorithm for the Etiological and Medico-Legal Management of Chronic Lung Diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07597187
Acronym
PNEUMO-LIBS
Enrollment
70
Registered
2026-05-19
Start date
2026-10-01
Completion date
2027-07-01
Last updated
2026-09-11

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

Conditions

Chronic Lung Diseases, Environmental Exposure, Interstitial Lung Diseases (ILD), Occupational Exposure, Occupational Lung Diseases, Pulmonary Emphysema

Brief summary

PNEUMO-LIBS is a multicenter, non-interventional observational study designed to evaluate whether multi-element tissue imaging by Laser-Induced Breakdown Spectroscopy (LIBS), combined with an artificial intelligence-based analysis tool called Interesting Features Finder (IFF), may help physicians better understand the possible causes of chronic lung diseases. The study focuses on adult patients with chronic lung diseases for which a lung biopsy has already been performed as part of routine medical care. These diseases include diffuse interstitial lung diseases, pulmonary granulomatoses such as sarcoidosis, and emphysema, especially when an environmental or occupational exposure is suspected but not clearly demonstrated. Some chronic lung diseases may be influenced by inhaled mineral or metallic particles, such as silica, aluminum, titanium, or other metals. However, these exposures are often difficult to document at the individual patient level. Standard clinical, radiological, and pathological investigations do not usually provide direct information on the presence and distribution of such elements within lung tissue. LIBS is an imaging technique that can detect and map chemical elements directly in tissue samples, including archived formalin-fixed paraffin-embedded biopsy blocks. In this study, lung biopsy samples will be analyzed with LIBS to search for elemental signatures that may be compatible with occupational or environmental exposures. The IFF algorithm will then be used to help interpret the LIBS data and identify rare or unexpected elemental signals. The study does not require any additional biopsy, blood test, imaging examination, treatment, or hospital visit for participants. It uses tissue samples and medical data already collected during routine care. The results of LIBS and IFF analyses will be presented to the treating physician or investigator, who will complete standardized online questionnaires at three time points: before receiving the LIBS results, after receiving the LIBS report, and after receiving the IFF-assisted interpretation. The main objective is to assess the perceived clinical utility of LIBS imaging for physicians, particularly regarding etiological understanding, possible occupational disease recognition, and prevention-oriented reasoning. Secondary objectives include assessing the added value of the IFF algorithm and evaluating the feasibility of a centralized multicenter workflow for sample transfer, LIBS analysis, IFF processing, result reporting, and questionnaire completion. The study aims to include approximately 70 patients across several French hospital centers. Its results may support the development of future diagnostic, occupational health, and environmental medicine approaches, without modifying the medical care of participants during the study.

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patient aged 18 years or older. * Diagnosis or documented clinical suspicion of chronic lung disease, including interstitial lung disease, pulmonary granulomatosis such as sarcoidosis, or pulmonary emphysema. * Availability of a lung tissue biopsy sample obtained during routine medical care and stored as a formalin-fixed paraffin-embedded sample. * Sufficient medical record information to document the clinical context, occupational or environmental exposure history, smoking status, imaging, pathology reports, and other relevant routine-care data. * No documented objection to the secondary use of health data and biological samples for this research.

Exclusion criteria

* Documented objection to participation in the study or to the secondary use of health data or biological samples for research. * Missing, unavailable, degraded, or technically unusable biopsy sample. * Insufficient medical record information to document the clinical context or exposure history. * Lung condition outside the scope of the study, such as isolated acute infection, isolated cardiac disease, or primary lung cancer. * Patient under legal protection when the applicable legal conditions for non-opposition cannot be fulfilled.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients With Perceived Added Clinical Value of LIBS ImagingAfter Review of the LIBS Report, Up to 1 Month After InclusionProportion of patients for whom the investigator reports that LIBS imaging provides new and clinically useful information in at least one of the following domains: etiological understanding, medico-legal reasoning regarding possible occupational disease recognition, or prevention-oriented recommendations.

Countries

France

Contacts

CONTACTBenoit BUSSER
BBusser@chu-grenoble.fr+33476768939
CONTACTVincent BONNETERRE
VBonneterre@chu-grenoble.fr+33476765851
PRINCIPAL_INVESTIGATORVincent BONNETERRE

CHU Grenoble Alpes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026