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

8 september 2026 bijgewerkt door: University Hospital, Grenoble

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

70

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Frankrijk
      • Grenoble, Frankrijk
      • Nancy, Frankrijk
        • Werving
        • Centre Hospitalier Régional Universitaire Nancy (CHRU)
        • Contact:
        • Hoofdonderzoeker:
          • Isabelle THAON
      • Rouen, Frankrijk
        • Werving
        • centre Hospitalier Universitaire Rouen (CHU)
        • Contact:
        • Hoofdonderzoeker:
          • Antoine GISLARD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adult patients with chronic lung diseases, including interstitial lung diseases, pulmonary granulomatoses such as sarcoidosis, and pulmonary emphysema, for whom a lung biopsy sample obtained during routine care is available for LIBS and IFF analysis. Participants may be identified retrospectively or prospectively in participating French hospital centers. Only patients who have not objected to the use of their health data and biological samples for research will be included.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Patients With Perceived Added Clinical Value of LIBS Imaging
Tijdsspanne: After Review of the LIBS Report, Up to 1 Month After Inclusion
Proportion 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.
After Review of the LIBS Report, Up to 1 Month After Inclusion

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Grenoble

Onderzoekers

  • Hoofdonderzoeker: Vincent BONNETERRE, CHU Grenoble Alpes

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 juli 2027

Studieregistratiedata

Eerst ingediend

12 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 september 2026

Laatste update ingediend die voldeed aan QC-criteria

8 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 38RC26.0001
  • 2026-A00164-47 (Andere identificatie: ID RCB)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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