E-Nose Breathprint Testing for Mesothelioma

Recruiting at 6 trial locations

Overseen By David Jones, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Thoracic cancer, Breast cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 1 year

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology called breathprinting, or E-Nose, to track responses to standard treatments for malignant pleural mesothelioma, a cancer affecting the lung lining. Researchers aim to determine if changes in breathprints align with changes seen in imaging scans and blood markers. Individuals recently diagnosed with this cancer, without a history of certain other cancers, might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance future cancer diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this E-Nose technology is safe for testing breathprints?

Research has shown that E-Nose technology is generally safe for people. Studies have found that this electronic nose can detect lung cancer by analyzing breath, with accuracy ranging from 71% to 96%. This means it can correctly identify most people who have the disease. The technology is non-invasive, as it doesn't involve surgery or internal tests.

The E-Nose has also distinguished between patients with conditions like malignant mesothelioma (a type of cancer linked to asbestos exposure) and those at risk but not showing symptoms. It achieves this by analyzing breath samples, making the process simple and straightforward.

No major reports of unexpected problems have emerged from the technology, suggesting that E-Nose testing is well-tolerated. However, as with any new technology, following study guidelines closely is important to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the E-Nose Breathprint Testing because it offers a non-invasive way to potentially detect mesothelioma earlier than current methods. Most standard treatments for mesothelioma, like surgery, chemotherapy, and radiation, focus on treating the disease after it has been diagnosed. In contrast, the E-Nose uses advanced technology to analyze a patient's breath for unique chemical signatures associated with mesothelioma. This could lead to earlier diagnosis and better outcomes for patients. The breath testing is quick and doesn't require the discomfort of more invasive procedures, making it a promising tool in the fight against this challenging disease.

What evidence suggests that E-Nose technology is effective for measuring responses to treatment in mesothelioma?

Research has shown that E-Nose technology, which participants in this trial will undergo, can detect changes in the breath of people with malignant pleural mesothelioma (MPM). One study found that the E-Nose could distinguish between patients responding well to treatment and those who were not. This tool functions like a high-tech sniffer, analyzing breath to identify specific patterns related to the disease. Early findings suggest it might offer a non-invasive way to track treatment effectiveness. Although still in the early stages, these results provide hope that E-Nose could become a valuable tool in managing MPM. ^{1 2 3 4 6}

Who Is on the Research Team?

Gaetano Rocco, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 signed all the necessary consent forms for the study and surgery.

Exclusion Criteria

I am either younger than 30 or older than 85.

I have a history of cancer that could spread to my lungs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard treatment for malignant pleural mesothelioma while undergoing E-Nose breathprinting tests

up to 1 year

Baseline and first three standard of care follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• E-Nose testing
• Research blood

Trial Overview

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.

How Is the Trial Designed?

Group I: E-Nose Technology Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

UNIVERSITY CAMPUS BIO-MEDICO, ITALY

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

Breath analysis using multicapillary column/ion mobility spectrometry (MCC/IMS) can effectively distinguish malignant pleural mesothelioma (MPM) patients from both former asbestos-exposed individuals and healthy controls, achieving 87% sensitivity and 70% specificity.

This method shows promise as a potential screening tool for early detection of MPM in at-risk populations, with an overall accuracy of 76% and an area under the ROC-curve of 0.81, indicating its effectiveness in identifying patients who may develop this cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of malignant pleural mesothelioma in exhaled breath by multicapillary column/ion mobility spectrometry (MCC/IMS). Lamote, K., Vynck, M., Van Cleemput, J., et al.[2022]

A breath test developed to differentiate asbestos-exposed individuals from pleural mesothelioma (PM) patients showed 100% sensitivity in correctly identifying PM patients, indicating its potential as an early diagnostic tool.

However, the test had a low specificity of 30%, leading to a high rate of false positives among asbestos-exposed individuals, which necessitates further testing and refinement before it can be used as a reliable screening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the clinical utility of a breath test for screening an asbestos-exposed population for pleural mesothelioma: baseline results. Zwijsen, K., Schillebeeckx, E., Janssens, E., et al.[2023]

Breath analysis is emerging as a promising noninvasive diagnostic tool for early detection of mesothelioma, which is crucial given the expected rise in cases due to past asbestos exposure.

High-throughput breathomics techniques can identify volatile organic compounds (VOCs) in breath, potentially serving as early diagnostic or prognostic biomarkers for asbestos-related pulmonary diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strengths, weaknesses, and opportunities of diagnostic breathomics in pleural mesothelioma-a hypothesis. Lamote, K., Nackaerts, K., van Meerbeeck, JP.[2022]

A study involving 20 malignant mesothelioma (MM) patients, 18 patients with benign asbestos-related diseases (ARDs), and 42 control subjects demonstrated that exhaled breath sampling using a carbon polymer array (CPA) electronic nose can accurately distinguish between these groups with 88% accuracy.

The CPA electronic nose achieved a remarkable 95% accuracy in identifying breath profiles of new MM patients, suggesting its potential as an effective screening tool for early detection of MM in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A breath test for malignant mesothelioma using an electronic nose. Chapman, EA., Thomas, PS., Stone, E., et al.[2022]

The study found that exhaled breath analysis using an electronic nose (eNose) can effectively distinguish between patients with malignant pleural mesothelioma who respond to immune checkpoint inhibitors (nivolumab plus ipilimumab) and those who do not, with a high accuracy rate of 71%.

The breath profiles of 31 patients showed significant differences between responders and non-responders at baseline, with a receiver-operating characteristic area under the curve (ROC-AUC) of 0.90, indicating that eNose technology could help identify patients who are likely to benefit from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nose in malignant mesothelioma-Prediction of response to immune checkpoint inhibitor treatment. Disselhorst, MJ., de Vries, R., Quispel-Janssen, J., et al.[2021]

Exhaled breath analysis shows promise as a non-invasive method for early detection of malignant pleural mesothelioma (MPM), with certain volatile organic compounds (VOCs) identified as potential biomarkers with high diagnostic accuracy.

The systematic review included six studies with sample sizes ranging from 39 to 330, indicating that while breath analysis can distinguish MPM from asbestos-exposed individuals, the small sample sizes and varied methodologies highlight the need for larger, standardized studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exhaled Breath Analysis in Diagnosis of Malignant Pleural Mesothelioma: Systematic Review. Töreyin, ZN., Ghosh, M., Göksel, Ö., et al.[2020]

The electronic nose (E-nose) technology demonstrated a 77% accuracy in classifying bronchoalveolar lavage (BAL) samples for diagnosing ventilator-associated pneumonia (VAP), showing promise as a diagnostic tool alongside traditional microbiological methods.

In patients not on antibiotics, the E-nose accurately identified 70% of cultured microbial isolates into clinically significant groups, indicating its potential for effective microbial species discrimination in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nose analysis of bronchoalveolar lavage fluid. Humphreys, L., Orme, RM., Moore, P., et al.[2021]

Recent advancements in biological monitoring techniques, such as breath analysis and flow cytometry, enhance the ability to assess worker exposure to harmful substances and their immune responses.

New molecular techniques are being developed to understand individual susceptibility to conditions like glomerulonephritis, and expert systems are being created to predict how chemicals affect skin permeability and sensitization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent policy and technical developments in biological monitoring in the United Kingdom. Wilson, HK.[2019]

The electronic nose is a promising non-invasive tool for diagnosing lung cancer by analyzing exhaled breath for specific volatile organic compounds, potentially serving as a biomarker for early detection.

This technology could be particularly beneficial in resource-limited settings where traditional screening methods, like low-dose computed tomography, may not be feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review on electronic nose for diagnosis and monitoring treatment response in lung cancer. Vadala, R., Pattnaik, B., Bangaru, S., et al.[2023]

The study found that an electronic nose, which analyzes exhaled gas from mechanically ventilated patients, correlates well with a clinical pneumonia score, showing a strong correlation coefficient of r = 0.81.

This innovative biosensor technology could potentially serve as a reliable tool for assessing pneumonia in intensive care settings, as indicated by the close agreement between the electronic nose predictions and actual pneumonia scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nose prediction of a clinical pneumonia score: biosensors and microbes. Hanson, CW., Thaler, ER.[2019]

In a pilot study involving 11 patients who underwent surgery for non-small cell lung cancer (NSCLC), continuous monitoring of exhaled breath temperature (EBT) showed potential for early detection of cancer relapse, as 5 patients who relapsed exhibited elevated EBT levels 6 months prior to diagnosis.

Patients without relapse demonstrated a decrease in EBT variability, suggesting that EBT monitoring could serve as a useful tool in distinguishing between patients at risk of relapse and those who are not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exhaled Breath Temperature Home Monitoring to Detect NSCLC Relapse: Results from a Pilot Study. Carpagnano, GE., Popov, TA., Scioscia, G., et al.[2022]

Breath analysis shows promise as a non-invasive method for identifying biomarkers of malignant pleural mesothelioma (MPM), based on a review of 15 studies published from 2000 to 2018, although these studies involved small sample sizes and preliminary data.

Despite the potential diagnostic accuracy of breath analysis for MPM, the findings are not yet generalizable or validated for clinical use, highlighting the need for further research to confirm these results and explore their application in monitoring treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breath Analysis: A Systematic Review of Volatile Organic Compounds (VOCs) in Diagnostic and Therapeutic Management of Pleural Mesothelioma. Catino, A., de Gennaro, G., Di Gilio, A., et al.[2023]

The Aeonose™ technology is being evaluated in a multi-centre study involving 210 subjects suspected of lung cancer, aiming to provide a fast and non-invasive method for early detection by analyzing volatile organic compounds in exhaled breath.

The study utilizes advanced data analysis techniques, including neural networks and cross-validation methods, to develop and validate prediction models that could enhance the diagnostic accuracy of lung cancer detection using breath analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data analysis of electronic nose technology in lung cancer: generating prediction models by means of Aethena. Kort, S., Brusse-Keizer, M., Gerritsen, JW., et al.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06037941

Study Details | NCT06037941 | Using E-Nose Technology ...

Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma. ClinicalTrials.gov ID NCT06037941.

2.

cancer.gov

cancer.gov/clinicaltrials/NCI-2023-07196

Using E-Nose Technology to Measure Response ...

This clinical trial evaluates electronic nose (E-Nose) technology in measuring response to treatment in patients with malignant pleural mesothelioma (MPM), ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7121878/

The electronic nose: emerging biomarkers in lung cancer ...

... data on E-nose technology for lung cancer detection. Short abstract. E-nose ... A breath test for malignant mesothelioma using an electronic nose. Eur ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0959804921002707

Nose in malignant mesothelioma—Prediction of response ...

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 ...

5.

oncotarget.com

oncotarget.com/article/21335/text/

Breath analysis by gas chromatography-mass spectrometry ...

... electronic nose (eNose). Methods: Breath and background samples were ... A breath test for malignant mesothelioma using an electronic nose.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/22183490/

A breath test for malignant mesothelioma using an ...

Exhaled breath VOC profiling can accurately distinguish between patients with MM, ARDs and controls using a CPA electronic nose.