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.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Benoit BUSSER
- 電話番号：+33476768939
- メール：BBusser@chu-grenoble.fr
研究連絡先のバックアップ
- 名前：Vincent BONNETERRE
- 電話番号：+33476765851
- メール：VBonneterre@chu-grenoble.fr
研究場所
-
-
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Grenoble、フランス
- 募集
- CHU Grenoble Alpes
-
コンタクト：
- Benoit BUSSER
- 電話番号：+33476768939
- メール：BBusser@chu-grenoble.fr
-
コンタクト：
- Vincent BONNETERRE
- 電話番号：33+ (0)4 76 76 58 51
- メール：VBonneterre@chu-grenoble.fr
-
Nancy、フランス
- 募集
- Centre Hospitalier Régional Universitaire Nancy (CHRU)
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コンタクト：
- Isabelle THAON
- 電話番号：33 3 83 15 71 71
- メール：i.thaon@chru-nancy.fr
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主任研究者：
- Isabelle THAON
-
Rouen、フランス
- 募集
- centre Hospitalier Universitaire Rouen (CHU)
-
コンタクト：
- Antoine GISLARD
- 電話番号：33 2 35 88 82 69
- メール：Antoine.Gislard@chu-rouen.fr
-
主任研究者：
- Antoine GISLARD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Patients With Perceived Added Clinical Value of LIBS Imaging
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Vincent BONNETERRE、CHU Grenoble Alpes
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 38RC26.0001
- 2026-A00164-47 (その他の識別子：ID RCB)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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