Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that E-Nose Breathprint Testing for Mesothelioma is an effective treatment?The available research shows that E-Nose Breathprint Testing has been effective in detecting lung cancer by analyzing breath samples. This technology measures specific compounds in the breath that are linked to lung cancer, helping in early detection. Although the studies focus on lung cancer, the success in identifying cancerous conditions suggests potential for similar effectiveness in mesothelioma. Compared to other methods, E-Nose testing is non-invasive and could be more accessible, especially in resource-limited settings.2371112
Is E-Nose Breathprint Testing a promising treatment for mesothelioma?Yes, E-Nose Breathprint Testing is promising because it can help detect mesothelioma early by analyzing breath samples. This early detection could improve survival rates for patients.4591013
What safety data exists for E-Nose Breathprint Testing for Mesothelioma?The available research primarily focuses on the diagnostic accuracy and potential of E-Nose Breathprint Testing for detecting malignant pleural mesothelioma (MPM) rather than its safety. Studies have shown promising results in distinguishing MPM patients from controls using breath analysis, but they emphasize the need for further research with larger sample sizes and standardized methodologies. There is no specific safety data mentioned in the provided research, indicating that more studies are needed to evaluate the safety aspects of this technology.168910
Eligibility Criteria
This trial is for adults aged 30-85 who have recently been diagnosed with malignant pleural mesothelioma (MPM) and haven't had thoracic cancer or cancers like breast, gastric, colon, or pancreas that could spread to the chest. Participants must consent to all study procedures.Inclusion Criteria
I am between 30 and 85 years old.
I have never had cancer in my chest or cancer from the breast, stomach, colon, or pancreas that has spread to the lining of my lungs.
I have recently been diagnosed with mesothelioma.
Exclusion Criteria
I am either younger than 30 or older than 85.
I have a history of cancer that could spread to my lungs.
Treatment Details
The study is testing E-Nose technology which analyzes breathprints to see how well patients respond to standard MPM treatments. It compares these breathprints over time with imaging scans and blood biomarkers related to MPM.
1Treatment groups
Experimental Treatment
Group I: E-Nose TechnologyExperimental Treatment2 Interventions
Patients undergo a breathprinting test (E-Nose) at baseline and at the first three standard of care follow-ups, as scheduled by their treating physician, that involve a CT of the Chest and/or PET/CT. The E-Nose testing will be administered by trained staff. Staff will use proper personal protective equipment during collections. Subjects will undergo E-Nose testing in a presurgical or interventional radiology suite. Subjects must consent to no smoking, no tooth brushing, and no food or drinks starting on midnight of the day of the E-Nose test. If fasting from midnight until the E-Nose test is not feasible, subjects may consent to fasting for 2 hours prior to each E-Nose test. Subjects opting to fast for 2 hours before each E-Nose test can only have still, non-carbonated water and non-aromatic foods or foods that do not develop aromatic compounds, such as low salt simple crackers, starting at midnight on the day of the E-Nose test until 2 hours before the collection.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Memorial Sloan Kettering Basking Ridge (Consent Only)Basking Ridge, NJ
Memorial Sloan Kettering Westchester (Consent Only)Harrison, NY
Memorial Sloan Kettering Monmouth (Consent Only)Middletown, NJ
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only)Commack, NY
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
UNIVERSITY CAMPUS BIO-MEDICO, ITALYCollaborator
References
Recent policy and technical developments in biological monitoring in the United Kingdom. [2019]In 1996 the United Kingdom's Health and Safety Executive introduced biological monitoring guidance values for six substances, butoxyethanol, N,N-dimethylacetamide, lindane, methylene-bis(2-chloroaniline), mercury and methylenedianiline. These guidance values were set as either health-based values or hygiene-based values calculate according to the 90th percentile (benchmark concept). Recent technical developments from the Health and Safety Laboratory are described in this paper and include: (i) the use of breath analysis as a useful non-invasive routine monitoring technique; (ii) flow cytometry as a means for measuring different patterns of immune cell activation from workers exposed to respiratory sensitisers when compared with those exposed to chemical irritants; (iii) the use of molecular techniques to explore the possible role of individual susceptibility in the development and severity of glomerulonephritis; (iv) the development of expert systems for predicting the skin permeability of chemicals, and respiratory and skin sensitisation.
Electronic nose prediction of a clinical pneumonia score: biosensors and microbes. [2019]The authors performed a prospective study to determine whether breath test analysis using an electronic nose correlates with a clinical pneumonia score.
Electronic nose analysis of bronchoalveolar lavage fluid. [2021]Electronic nose (E-nose) technology has been successfully used to diagnose a number of microbial infections. We have investigated the potential use of an E-nose for the diagnosis of ventilator-associated pneumonia (VAP) by detecting micro-organisms in bronchoalveolar lavage (BAL) fluid in a prospective comparative study of E-nose analysis and microbiology.
A breath test for malignant mesothelioma using an electronic nose. [2022]Malignant mesothelioma (MM) is a rare tumour which is difficult to diagnose in its early stages. Earlier detection of MM could potentially improve survival. Exhaled breath sampling of volatile organic compounds (VOCs) using a carbon polymer array (CPA) electronic nose recognises specific breath profiles characteristic of different diseases, and can distinguish between patients with lung cancer and controls. With MM, the potential confounding effect of other asbestos-related diseases (ARDs) needs to be considered. We hypothesised that as CPA electronic nose would distinguish patients with MM, patients with benign ARDs, and controls with high sensitivity and specificity. 20 MM, 18 ARD and 42 control subjects participated in a cross-sectional, case-control study. Breath samples were analysed using the Cyranose 320 (Smiths Detection, Pasadena, CA, USA), using canonical discriminant analysis and principal component reduction. 10 MM subjects created the training set. Smell prints from 10 new MM patients were distinguished from control subjects with an accuracy of 95%. Patients with MM, ARDs and control subjects were correctly identified in 88% of cases. Exhaled breath VOC profiling can accurately distinguish between patients with MM, ARDs and controls using a CPA electronic nose. This could eventually translate into a screening tool for high-risk populations.
Strengths, weaknesses, and opportunities of diagnostic breathomics in pleural mesothelioma-a hypothesis. [2022]Past and present asbestos use will reflect in increasing numbers of mesothelioma cases in the next decades, diagnosed at a late stage and with a dismal prognosis. This stresses the need for early detection tools, which could improve patients' survival. Recently, breath analysis as a noninvasive and fast diagnostic tool has found its way into biomedical research. High-throughput breathomics uses spectrometric, chromatographic, and sensor techniques to diagnose asbestos-related pulmonary diseases based upon volatile organic compounds (VOC) in breath. This article reviews the state-of-the-art available breath analyzing techniques and provides the insight in the current use of VOCs as early diagnostic or prognostic biomarkers of mesothelioma to stimulate further research in this field. Cancer Epidemiol Biomarkers Prev; 23(6); 898-908. ©2014 AACR.
Detection of malignant pleural mesothelioma in exhaled breath by multicapillary column/ion mobility spectrometry (MCC/IMS). [2022]Malignant pleural mesothelioma (MPM) is predominantly caused by previous asbestos exposure. Diagnosis often happens in advanced stages restricting any therapeutic perspectives. Early stage detection via breath analysis was explored using multicapillary column/ion mobility spectrometry (MCC/IMS) to detect volatile organic compounds (VOCs) in the exhaled breath of MPM patients in comparison to former occupational asbestos-exposed and non-exposed controls. Breath and background samples of 23 MPM patients, 22 asymptomatic former asbestos (AEx) workers and 21 healthy non-asbestos exposed persons were taken for analysis. After background correction, we performed a logistic least absolute shrinkage and selection operator (lasso) regression to select the most important VOCs, followed by receiver operating characteristic (ROC) analysis. MPM patients were discriminated from both controls with 87% sensitivity, 70% specificity and respective positive and negative predictive values of 61% and 91%. The overall accuracy was 76% and the area under the ROC-curve was 0.81. AEx individuals could be discriminated from MPM patients with 87% sensitivity, 86% specificity and respective positive and negative predictive values of 87% and 86%. The overall accuracy was 87% with an area under the ROC-curve of 0.86. Breath analysis by MCC/IMS allows MPM patients to be discriminated from controls and holds promise for further investigation as a screening tool for former asbestos-exposed persons at risk of developing MPM.
Data analysis of electronic nose technology in lung cancer: generating prediction models by means of Aethena. [2019]Only 15% of lung cancer cases present with potentially curable disease. Therefore, there is much interest in a fast, non-invasive tool to detect lung cancer earlier. Exhaled breath analysis using electronic nose technology measures volatile organic compounds (VOCs) in exhaled breath that are associated with lung cancer.
Breath Analysis: A Systematic Review of Volatile Organic Compounds (VOCs) in Diagnostic and Therapeutic Management of Pleural Mesothelioma. [2023]Malignant pleural mesothelioma (MPM) is a rare neoplasm related to asbestos exposure and with high mortality rate. The management of patients with MPM is complex and controversial, particularly with regard to early diagnosis. In the last few years, breath analysis has been greatly implemented with this aim. In this review the strengths of breath analysis and preliminary results in searching breath biomarkers of MPM are highlighted and discussed, respectively. Through a systematic electronic literature search, collecting papers published from 2000 until December 2018, fifteen relevant scientific papers were selected. All papers considered were prospective, comparative, observational case-control studies although every single one pilot and based on a relatively small number of samples. The identification of diagnostic VOCs pattern, through breath sample characterization and the statistical data treatment, allows to obtain a strategic information for clinical diagnostics. To date the collected data provide just preliminary information and, despite the promising results and diagnostic accuracy, conclusions cannot be generalized due to the limited number of individuals included in each cohort study. Furthermore none of studies was externally validated, although validation process is a necessary step towards clinical implementation. Breathomics-based biomarker approach should be further explored to confirm and validate preliminary findings and to evaluate its potential role in monitoring the therapeutic response.
Exhaled Breath Analysis in Diagnosis of Malignant Pleural Mesothelioma: Systematic Review. [2020]Malignant pleural mesothelioma (MPM) is mainly related to previous asbestos exposure. There is still dearth of information on non-invasive biomarkers to detect MPM at early stages. Human studies on exhaled breath biomarkers of cancer and asbestos-related diseases show encouraging results. The aim of this systematic review was to provide an overview on the current knowledge about exhaled breath analysis in MPM diagnosis. A systematic review was conducted on MEDLINE (PubMed), EMBASE and Web of Science databases to identify relevant studies. Quality assessment was done by the Newcastle-Ottawa Scale. Six studies were identified, all of which showed fair quality and explored volatile organic compounds (VOC) based breath profile using Gas Chromatography Coupled to Mass Spectrometry (GC-MS), Ion Mobility Spectrometry Coupled to Multi-capillary Columns (IMS-MCC) or pattern-recognition technologies. Sample sizes varied between 39 and 330. Some compounds (i.e, cyclohexane, P3, P5, P50, P71, diethyl ether, limonene, nonanal, VOC IK 1287) that can be indicative of MPM development in asbestos exposed population were identified with high diagnostic accuracy rates. E-nose studies reported breathprints being able to distinguish MPM from asbestos exposed individuals with high sensitivity and a negative predictive value. Small sample sizes and methodological diversities among studies limit the translation of results into clinical practice. More prospective studies with standardized methodologies should be conducted on larger populations.
Nose in malignant mesothelioma-Prediction of response to immune checkpoint inhibitor treatment. [2021]Recent clinical trials with immune checkpoint inhibitors (ICIs) have shown that a subgroup of patients with malignant pleural mesothelioma (MPM) could benefit from these agents. However, there are no accurate biomarkers to predict who will respond. The aim of this study was to assess the accuracy of exhaled breath analysis using electronic technology (eNose) for discriminating between responders to ICI and non-responders.
Exhaled Breath Temperature Home Monitoring to Detect NSCLC Relapse: Results from a Pilot Study. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Exhaled breath temperature (EBT) has been shown to reflect airway inflammation as well as increased vascularization, both involved in the pathogenesis of lung cancer. The aim of this study was to look for evidence that continuous EBT monitoring by such a device may help the early detection of relapse of lung cancer in patients with NSCLC who have been subjected to surgery with radical intent. Case Series. We included 11 subjects, who had been subjected to lung resection with radical intent for NSCLC in a prospective observational study. All patients received individual devices for EBT measurement and used them daily for 24 months after surgery. Subjects were also followed up by means of regular standard-of-care clinical and radiologic monitoring for lung cancer at four intervals separated by 6 months (T0, T1, T2, T3, and T4). In 5 patients, relapse of lung cancer was documented by means of lung biopsies. All of them recorded an elevation of their EBT at least one-time interval (T1), corresponding to 6 months, before the relapse was diagnosed at T4. The individual EBT graphs over time differed among these patients, and their mean EBT variability increased by +4% towards the end of 24 months of monitoring. By contrast, patients without a relapse did not document an elevation of their EBT and their variability decreased by -1.4%.
A review on electronic nose for diagnosis and monitoring treatment response in lung cancer. [2023]Lung cancer is one of the common malignancies with high mortality rate and a poor prognosis. Most lung cancer cases are diagnosed at an advanced stage either due to limited resources of infrastructure, trained human resources, or delay in clinical suspicion. Low-dose computed tomography has emerged as a screening tool for lung cancer detection but this may not be a feasible option for most developing countries. Electronic nose is a unique non-invasive device that has been developed for lung cancer diagnosis and monitoring response by exhaled breath analysis of volatile organic compounds. The breath-print have been shown to differ not only among lung cancer and other respiratory diseases, but also between various types of lung cancer. Hence, we postulate that the breath-print analysis by electronic nose could be a potential biomarker for the early detection of lung cancer along with monitoring treatment response in a resource-limited setting. In this review, we have consolidated the current published literature suggesting the use of an electronic nose in the diagnosis and monitoring treatment response of lung cancer.
Determining the clinical utility of a breath test for screening an asbestos-exposed population for pleural mesothelioma: baseline results. [2023]Pleural mesothelioma (PM) is an aggressive cancer of the serosal lining of the thoracic cavity, predominantly caused by asbestos exposure. Due to nonspecific symptoms, PM is characterized by an advanced-stage diagnosis, resulting in a dismal prognosis. However, early diagnosis improves patient outcome. Currently, no diagnostic biomarkers or screening tools are available. Therefore, exhaled breath was explored as this can easily be obtained and contains volatile organic compounds, which are considered biomarkers for multiple (patho)physiological processes. A breath test, which differentiates asbestos-exposed (AEx) individuals from PM patients with 87% accuracy, was developed. However, before being implemented as a screening tool, the clinical utility of the test must be determined. Occupational AEx individuals underwent annual breath tests using multicapillary column/ion mobility spectrometry. A baseline breath test was taken and their individual risk of PM was estimated. PM patients were included as controls. In total, 112 AEx individuals and six PM patients were included in the first of four screening rounds. All six PM patients were correctly classified as having mesothelioma (100% sensitivity) and out of 112 AEx individuals 78 were classified by the breath-based model as PM patients (30% specificity). Given the large false positive outcome, the breath test will be repeated annually for three more consecutive years to adhere to the 'test, re-test' principle and improve the false positivity rate. A low-dose computed tomography scan in those with two consecutive positive tests will correlate test positives with radiological findings and the possible growth of a pleural tumor. Finally, the evaluation of the clinical value of a breath-based prediction model may lead to the initiation of a screening program for early detection of PM in Aex individuals, which is currently lacking. This clinical study received approval from the Antwerp University Hospital Ethics Committee (B300201837007).