Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy)

Idiopathic Pulmonary Fibrosis Clinical Trial

— MEDICO-LIBS  

Official title:

Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy) : a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03901196
• Other study ID #: 38RC18.134
• Secondary ID: 2019-A00070-57
• Status: Recruiting
• Start date: January 22, 2020
• Est. completion date: January 22, 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Grenoble
• Contact: Benoit Busser, PharmD, PhD
• Phone: +33 4 76 76 89 39
• Email: bbusser[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluate the feasibility of performing a multi-elemental imaging analysis of lung specimens from patients with ILDs, with an technology named LIBS (Laser Induced-Breakdown Spectroscopy)

Description:

There is a major health problem due to the environmental and occupational related exposures to mineral particles, metals, and dust. The impact on health is considerable in terms of prevalence, morbidity and healthcare costs. Pathologists rarely report the presence of a possible mineral or metal-related etiology in a specimen by lack of available and convenient technology. Therefore, several respiratory diseases are considered idiopathic.

Interstitial lung disease (ILD), also known as diffuse parenchymal lung disease (DPLD) is a group of lung diseases affecting the interstitium (the tissue and space around the air sacs of the lungs). In France, 15.000 new cases of ILD are diagnosed each year. ILD may be classified according to the cause. Idiopathic ILD are ILD of unknown causes. The most frequent idiopathic ILD are sarcoidosis and idiopathic pulmonary fibrosis (IPF).These two diseases are the core topic of the present study since they may relate to important mineral or metal exposure.

The overall goal of this MEDICO-LIBS study is to evaluate the feasibility of using a laser-induced breakdown spectroscopy (LIBS)-based instrument to image(ie, identify, localize and possibly quantify) metals within selected human specimens with ILDs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 22, 2025
• Est. primary completion date: January 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with ILD

• Patient informed, and agreed to participate

Exclusion Criteria:

• Patient opposed to participating in the study.

• Patient without available specimen.

• Patient under legal protection

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis
• Sarcoidosis

Intervention

Diagnostic Test:
• Elemental analysis
LIBS multi elemental analysis of the specimen

Locations

Country	Name	City	State
France	Grenoble Alpes University Hospital	Grenoble
France	CHRU de LILLE	Lille
France	CHU de Lyon HCL - GH Sud	Lyon
France	Hôpital Louis Pradel	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (2)

Busser B, Moncayo S, Trichard F, Bonneterre V, Pinel N, Pelascini F, Dugourd P, Coll JL, D'Incan M, Charles J, Motto-Ros V, Sancey L. Characterization of foreign materials in paraffin-embedded pathological specimens using in situ multi-elemental imaging w — View Citation

Busser et al., Coord Chem Rev, 2018, 358, p70

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generation of multi-elemental images in tissues with LIBS	Evaluation of the feasibility of collecting and describing LIBS multi-elemental images of lung specimens originating from patients with ILDs	Within a month after reception of the biopsy by the analytical laboratory
Secondary	Description of elemental distribution in the specimens	Comprehensive chemical characterization of both endogenous and exogenous elements for each specimen	Within a month after reception of the biopsy by the analytical laboratory
Secondary	Interpretation of the elemental maps	Understanding of the elemental distribution according to the clinical data	Within a month after reception of the biopsy by the analytical laboratory
Secondary	Comparison of the elemental distributions with results of other mineralogical investigations	Only for patients who previously benefited from other mineralogical investigations (eg, SEM-EDX), comparison of mineralogical analysis obtained with the elemental distributions obtained with LIBS	Within a month after reception of the biopsy by the analytical laboratory