Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma

Study Overview
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Brief Summary
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The researchers are doing this study to test the ability of a new technology called breathprinting, or electronic nose (E-Nose), to measure how people respond to standard treatment for malignant pleural mesothelioma (MPM). The researchers will study how E-Nose breathprints change over time as people receive standard treatment for MPM. They will also look at how changes in people's E-Nose breathprints compare to changes in their standard imaging scans and in biomarkers of MPM in their blood.

Official Title
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Breathprinting (E-Nose) Technology to Measure Response to Treatment of Malignant Pleural Mesothelioma (MPM) Through MPM-Specific Volatile Organic Compounds Detected in Exhalates

Conditions
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Malignant Pleural Mesothelioma

Intervention / Treatment
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* Diagnostic Test: E-Nose testing
* Diagnostic Test: Research blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 30-85 years No history of thoracic cancer or extrathoracic cancer potentially involving pleural metastases (i.e., breast, gastric, colon, or pancreas cancer) Recent diagnosis of MPM Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study, and signed standard surgical consent for surgical resection Exclusion Criteria: Aged <30 or >85 years at the first outpatient visit History of thoracic or extrathoracic cancer that puts the subject at risk for pleural or pulmonary metastases

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-Nose Technology<br>Patients will undergo E-Nose testing at baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). Patients will undergo E-Nose testing in a presurgical or interventional radiology suite. | Diagnostic Test: E-Nose testing<br>* At baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). A breath sample from each patient will be captured in a cartridge, which will form the basis for the E-Nose analysis, to be performed by study investigators at UCB.<br>Diagnostic Test: Research blood<br>* Research blood tests will be obtained at baseline, 1, 3, and 6 months post-treatment to determine whether serum biomarkers of MPM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of MPMspecific VOCs | compared with imaging (using RECIST 1.1). | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breathprinting (E-Nose) Technology, MPM-Specific Volatile Organic Compounds, 23-100