Interstitial Lung DiseaseMEDICO-LIBSNCT03901196
Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy)
An observational study of Interstitial Lung Disease and Sarcoidosis, run by University Hospital, Grenoble at 4 sites in France.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Sarcoidosis, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Elemental analysis
- How many people
- 86 participants
- Where
- 4 sitesFrance
- Study dates
- 22 Jan 2020to 9 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Interstitial Lung Disease
Who may be able to join
- Patient with ILD
- Patient informed, and agreed to participate
Who cannot join
- Patient opposed to participating in the study.
- Patient without available specimen.
- Patient under legal protection
Trial locations and contacts
4 sites in 1 country.
France4 sites
Grenoble Alpes University Hospital
Grenoble, 38043
CHRU de LILLE
Lille, 59000
CHU de Lyon HCL - GH Sud
Lyon, 69310
Hôpital Louis Pradel
Lyon, 69677
About this study
Official title: 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)
Read the 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.
- Being tested
- Elemental analysis
- Keywords
- Laser Induced Breakdown Spectroscopy, Multi elemental imaging
- Medical subject headings
- Lung Diseases, Interstitial, Sarcoidosis, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemental analysisDiagnostic test
LIBS multi elemental analysis of the specimen
| Study group | Role | What they receive |
|---|---|---|
| Interstitial Lung Disease | Ex : sarcoidosis, IPF Receives: Diagnostic Test: Elemental analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within a month after reception of the biopsy by the analytical laboratory
Secondary outcomes (3)
Description of elemental distribution in the specimens
Comprehensive chemical characterization of both endogenous and exogenous elements for each specimen
Measured: Within a month after reception of the biopsy by the analytical laboratory
Interpretation of the elemental maps
Understanding of the elemental distribution according to the clinical data
Measured: Within a month after reception of the biopsy by the analytical laboratory
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
Measured: Within a month after reception of the biopsy by the analytical laboratory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start22 Jan 2020
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Busser, PharmD, PhD, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901196
- Sponsor's protocol ID
- 38RC18.134
- Other IDs
- 2019-A00070-57
- Acronym
- MEDICO-LIBS
- Status last verified
- Aug 2024
- First submitted
- 28 Mar 2019
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 with laser spectroscopy. Mod Pathol. 2018 Mar;31(3):378-384. doi: 10.1038/modpathol.2017.152. Epub 2017 Nov 17.
PubMed 29148536Busser et al., Coord Chem Rev, 2018, 358, p70
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy) : a Feasibility Study
- ClinicalTrials.gov ID
- NCT03901196
- Acronym / sponsor ID
- MEDICO-LIBS / 38RC18.134
- Keywords
- Laser Induced Breakdown Spectroscopy, Multi elemental imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interstitial Lung Disease | – | Diagnostic Test: Elemental analysisEx : sarcoidosis, IPF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Interstitial Lung Disease
Key inclusion criteria (2 listed)
- Patient with ILD
- Patient informed, and agreed to participate
Key exclusion criteria (3 listed)
- Patient opposed to participating in the study.
- Patient without available specimen.
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elemental analysisLIBS multi elemental analysis of the specimen | Diagnostic test | Interstitial Lung Disease |
Primary outcome
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
3 secondary outcomes
Description of elemental distribution in the specimens
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Results publication: PubMed 29148536Busser 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 with laser spectroscopy. Mod Pathol. 2018 Mar;31(3):378-384. doi: 10.1038/modpathol.2017.152. Epub 2017 Nov 17.
- Results publicationBusser et al., Coord Chem Rev, 2018, 358, p70
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Busser, PharmD, PhD principal investigator
Grenoble Alpes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Sarcoidosis, run by University Hospital, Grenoble at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of multi-elemental images in tissues with LIBS (time frame: Within a month after reception of the biopsy by the analytical laboratory). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901196, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.