E-Nose Breathprint Testing for Mesothelioma

Recruiting at6 trial locations

Overseen by Gaetano Rocco, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Thoracic cancer, Breast cancer, others

No Placebo Group

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.

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 data supports the effectiveness of the E-Nose Breathprint Testing treatment for Mesothelioma?

Electronic nose technology has been shown to effectively detect lung cancer by analyzing exhaled breath for specific compounds, suggesting it could be useful for early detection of other respiratory diseases like mesothelioma. ^{1 2 3 4 5}

Is E-Nose Breathprint Testing safe for humans?

E-Nose Breathprint Testing, which involves analyzing exhaled breath, is generally considered safe as it is a non-invasive method, meaning it doesn't require surgery or entering the body. ^{6 7 8 9 10}

How does the E-Nose Breathprint Testing treatment for mesothelioma differ from other treatments?

The E-Nose Breathprint Testing is unique because it uses a non-invasive breath analysis to detect volatile organic compounds (VOCs) specific to mesothelioma, potentially allowing for earlier diagnosis compared to traditional methods. This approach is novel as it focuses on identifying disease-specific breath profiles, which could lead to a screening tool for high-risk populations, unlike existing treatments that typically address the disease after diagnosis. ^{7 8 11 12 13}

Research Team

Gaetano Rocco, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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 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.

Trial Timeline

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

Treatment Details

Interventions

• E-Nose testing (Procedure)
• Research blood (Procedure)

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.

Participant Groups

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+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

UNIVERSITY CAMPUS BIO-MEDICO, ITALY

Collaborator

Trials

1

Recruited

20+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Data analysis of electronic nose technology in lung cancer: generating prediction models by means of Aethena. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Electronic nose analysis of bronchoalveolar lavage fluid. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A review on electronic nose for diagnosis and monitoring treatment response in lung cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Electronic nose prediction of a clinical pneumonia score: biosensors and microbes. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Exhaled Breath Temperature Home Monitoring to Detect NSCLC Relapse: Results from a Pilot Study. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Nose in malignant mesothelioma-Prediction of response to immune checkpoint inhibitor treatment. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Exhaled Breath Analysis in Diagnosis of Malignant Pleural Mesothelioma: Systematic Review. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Detection of malignant pleural mesothelioma in exhaled breath by multicapillary column/ion mobility spectrometry (MCC/IMS). [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Breath Analysis: A Systematic Review of Volatile Organic Compounds (VOCs) in Diagnostic and Therapeutic Management of Pleural Mesothelioma. [2023]

11. England pubmed.ncbi.nlm.nih.gov

A breath test for malignant mesothelioma using an electronic nose. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Determining the clinical utility of a breath test for screening an asbestos-exposed population for pleural mesothelioma: baseline results. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Strengths, weaknesses, and opportunities of diagnostic breathomics in pleural mesothelioma-a hypothesis. [2022]