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

August 4, 2023 updated by: University Hospital, Grenoble

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with Interstitial Lung Disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interstitial Lung Disease
Ex : sarcoidosis, IPF
Diagnostic test: Elemental analysis
LIBS multi elemental analysis of the specimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generation of multi-elemental images in tissues with LIBS
Time Frame: Within a month after reception of the biopsy by the analytical laboratory
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of elemental distribution in the specimens
Time Frame: Within a month after reception of the biopsy by the analytical laboratory
Comprehensive chemical characterization of both endogenous and exogenous elements for each specimen
Within a month after reception of the biopsy by the analytical laboratory
Interpretation of the elemental maps
Time Frame: Within a month after reception of the biopsy by the analytical laboratory
Understanding of the elemental distribution according to the clinical data
Within a month after reception of the biopsy by the analytical laboratory
Comparison of the elemental distributions with results of other mineralogical investigations
Time Frame: Within a month after reception of the biopsy by the analytical laboratory
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Benoit Busser, PharmD, PhD, Grenoble Alpes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2020

Primary Completion (Estimated)

January 22, 2025

Study Completion (Estimated)

January 22, 2025

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC18.134
  • 2019-A00070-57 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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