Clinical Utility of LIBS Multi-Element Imaging and the IFF Algorithm in Chronic Lung Diseases (PNEUMO-LIBS)
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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Benoit BUSSER
- 전화번호: +33476768939
- 이메일: BBusser@chu-grenoble.fr
연구 연락처 백업
- 이름: Vincent BONNETERRE
- 전화번호: +33476765851
- 이메일: VBonneterre@chu-grenoble.fr
연구 장소
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-
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Grenoble, 프랑스
- 모병
- CHU Grenoble Alpes
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연락하다:
- Benoit BUSSER
- 전화번호: +33476768939
- 이메일: BBusser@chu-grenoble.fr
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연락하다:
- Vincent BONNETERRE
- 전화번호: 33+ (0)4 76 76 58 51
- 이메일: VBonneterre@chu-grenoble.fr
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Nancy, 프랑스
- 모병
- Centre Hospitalier Régional Universitaire Nancy (CHRU)
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연락하다:
- Isabelle THAON
- 전화번호: 33 3 83 15 71 71
- 이메일: i.thaon@chru-nancy.fr
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수석 연구원:
- Isabelle THAON
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Rouen, 프랑스
- 모병
- centre Hospitalier Universitaire Rouen (CHU)
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연락하다:
- Antoine GISLARD
- 전화번호: 33 2 35 88 82 69
- 이메일: Antoine.Gislard@chu-rouen.fr
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수석 연구원:
- Antoine GISLARD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Patients With Perceived Added Clinical Value of LIBS Imaging
기간: After Review of the LIBS Report, Up to 1 Month After Inclusion
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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.
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After Review of the LIBS Report, Up to 1 Month After Inclusion
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공동 작업자 및 조사자
수사관
- 수석 연구원: Vincent BONNETERRE, CHU Grenoble Alpes
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 38RC26.0001
- 2026-A00164-47 (기타 식별자: ID RCB)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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