e-Nose Technology for Lung Cancer

Not currently recruiting at 8 trial locations

Overseen By David Jones, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Multiple nodules, Previous lung cancer, Metastatic, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology called the electronic nose (e-nose) for detecting early-stage lung cancer. The e-nose "sniffs" a breath sample to identify lung cancer, particularly in cases with larger tumors. It is suitable for individuals with a lung nodule (a small mass of tissue) visible on a CT scan that might be cancerous and who are candidates for further procedures to check or remove the nodule. As a Phase 2 trial, this research measures the e-nose's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to advancements in early detection.

Do I need to stop my current medications for the trial?

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

What prior data suggests that this breathprinting test is safe for detecting lung cancer?

Research has shown that electronic nose (e-nose) technology, used in breath tests, holds promise for detecting lung cancer. This technology identifies certain chemicals in breath, known as volatile organic compounds (VOCs), which can indicate cancer.

In past studies, e-nose devices demonstrated high accuracy in detecting lung cancer. One study found the test was correct 91% of the time, identifying cancer in 91 out of 100 cases. The study also reported a sensitivity of 75% and a specificity of 96%. Sensitivity measures how often the test correctly identifies people with the disease, while specificity measures how often it correctly identifies people without the disease.

Breath tests are safe because they are non-invasive, not involving surgery or inserting instruments into the body. No reports of harmful effects from using e-nose technology exist, and patients seem to tolerate it well. However, as this technology is still new, researchers continue to gather more information on its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the breathprinting test because it uses e-nose technology to detect early lung cancer through a simple breath analysis. Unlike traditional methods that rely on invasive procedures like biopsies or more expensive imaging techniques such as CT and PET scans, this test offers a non-invasive, quick, and potentially cost-effective alternative. The e-nose can identify unique chemical signatures in the breath, which could lead to earlier detection and treatment of lung cancer. This innovation could simplify the diagnostic process and improve outcomes for patients with undiagnosed pulmonary nodules.

What evidence suggests that the breathprinting test is effective for detecting early-stage lung cancer?

This trial will evaluate the effectiveness of the Breathprinting Test, specifically the e-nose, in detecting lung cancer in participants with an undiagnosed pulmonary nodule. Studies have shown that breath tests like the e-nose can effectively detect lung cancer. Research indicates that this technology can differentiate between cancerous and non-cancerous breath samples with high accuracy, correctly identifying most cancer cases. One study found that a breath test could distinguish between lung cancer and non-cancerous lung nodules. Another study reported a 98% accuracy rate for identifying cancer, although it was less accurate in identifying non-cancerous cases. This suggests that the e-nose holds promise for early lung cancer detection, especially in identifying cancerous changes from breath samples. ^{4 6 7 8 9}

Who Is on the Research Team?

Gaetano Rocco, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

MSK radiologist report or read suggestive (i.e. at least 50% certainty) of suspected primary lung cancer (in accordance with the level of certainty criteria set forth by MSKCC Radiology)

Negative test for COVID-19 performed locally or at MSK, done as part of standard of care testing (i.e. only when required by specific institutional policy) prior to biopsy or surgical procedure

Eligible for fine-needle aspiration biopsy, robotic bronchoscopy, and/or surgical resection for diagnosis (i.e., does not have comorbidities precluding these).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants undergo e-nose testing to determine disease status

up to 1 month

Follow-up

Participants are monitored for safety and effectiveness after diagnostic testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Breathprinting Test

How Is the Trial Designed?

Group I: Participants with an Undiagnosed Pulmonary Nodule Experimental Treatment 1 Intervention

One hundred evaluable individuals aged 21 to 85 years with a single undiagnosed pulmonary nodule measuring \<3 cm, clinically staged as cT1N0M0 (eighth edition of the TNM staging manual) by CT and PET scans, will be enrolled in this diagnostic study and will undergo e-nose testing. These patients must have a risk assessment profile that, according to institutional guidelines, identifies them as candidates for subsequent surgical resection of the pulmonary nodule, which will confirm the results of the breathprinting analysis.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10272389/

a comparison of the breath test and 18F-FDG PET-CT - PMC Overall, the study demonstrated the efficacy of a breath test utilizing HPPI-TOFMS for discriminating lung cancer from benign pulmonary nodules.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04734145

Using e-Nose Technology to Identify Early Lung Cancer The purpose of this study is to test the ability of a new technology called breathprinting, or electronic nose (e-nose), to detect early-stage lung cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1556086424002119

A Real-World Assessment of Stage I Lung Cancer Through ... This study leveraged a training data set including 657 breathprints from a population that includes healthy controls, individuals diagnosed with chronic ...

4. journal.chestnet.org journal.chestnet.org/article/S0012-3692(13)60291-3/fulltext

Evaluation of Individuals With Pulmonary Nodules: When Is It ... Qualitative assessment and subjective weighting of these features yielded a sensitivity of 98% for identifying malignancy but a specificity of only 23%. Data ...

5. link.springer.com link.springer.com/article/10.1007/s00408-025-00828-0

Electronic-Nose Technology for Lung Cancer Detection Results. E-noses have demonstrated high sensitivity and specificity in differentiating cancerous from non-cancerous breath samples. However, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3749714/

Evaluation of Individuals With Pulmonary Nodules Individuals with pulmonary nodules should be evaluated and managed by estimating the probability of malignancy, performing imaging tests to better characterize ...

7. aafp.org aafp.org/pubs/afp/issues/2023/0300/pulmonary-nodules.html

Pulmonary Nodules: Common Questions and Answers Pulmonary nodules are often incidentally discovered on chest imaging or from dedicated lung cancer screening.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0925400524014655

Device set up and pilot test in the longitudinal study of lung ... Postoperative breath fingerprint detected lung cancer recurrence: accuracy 91 %, sensitivity 75 %, specificity 96 %, PPV 86 % and NPV 93 %.

9. researchgate.net researchgate.net/publication/369126797_Breathprinting_analysis_and_biomimetic_sensor_technology_to_detect_lung_cancer

Breathprinting analysis and biomimetic sensor technology ... Combining exhaled-breath data with clinical parameters may improve lung cancer diagnosis. ... A nanomaterial-based breath test for short-term ...