E-Nose Technology for Lung Cancer

Recruiting at 6 trial locations

Overseen By Gaetano Gaetano, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: None

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology called E-Nose, which can detect changes in the breath of people with non-small cell lung cancer (NSCLC). The goal is to evaluate how effectively this technology identifies chemical changes in the breath before and after standard treatments. Individuals with stage I NSCLC undergoing surgery or those with stage II to IIIB NSCLC receiving pre-surgery treatment may be suitable candidates. The trial involves collecting breath samples at various times, a simple, noninvasive process known as Breathprinting. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 E-Nose technology is safe for use in lung cancer patients?

Research has shown that E-Nose technology, also known as breathprinting, is a promising method for detecting lung cancer. Studies suggest it is safe and well-tolerated by individuals. The E-Nose is non-invasive, as it does not involve surgery or internal exams. Instead, it analyzes breath for specific chemicals linked to lung cancer.

No major reports of harmful side effects have emerged from using this technology. The process is similar to taking a deep breath and exhaling into a device, making it easy and comfortable for most people.

While researchers continue to test the technology, it has demonstrated excellent accuracy in identifying lung cancer. This suggests the device is reliable and safe for use in clinical settings. For personalized information, discussing concerns with the trial team is recommended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about breathprinting for lung cancer because it offers a non-invasive way to detect and monitor the disease. Unlike traditional methods like biopsies or imaging, which can be invasive or expose patients to radiation, breathprinting uses an "E-Nose" technology to analyze volatile organic compounds in a patient's breath. This innovative approach aims to provide quicker, more comfortable assessments of how well a treatment is working or if cancer has returned. This could lead to more personalized and timely treatment adjustments for patients with lung cancer.

What evidence suggests that E-Nose technology is effective for lung cancer?

This trial will evaluate E-Nose technology, which could help detect lung cancer by analyzing breath samples. Participants will be divided into two cohorts: Cohort 1 includes patients with stage II to IIIB NSCLC undergoing neoadjuvant treatment, and Cohort 2 includes patients with stage I NSCLC planned for upfront surgery. Research has shown that E-Nose technology can accurately distinguish between cancerous and non-cancerous breath samples, potentially providing quick and accurate lung cancer diagnoses. Previous findings suggest it works well, especially for detecting early-stage lung cancer. Although more research is needed, early results are promising for using E-Nose to monitor lung cancer treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

David Jones, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with Non-Small Cell Lung Cancer (NSCLC) who are about to undergo standard neoadjuvant therapy. Specific eligibility criteria details were not provided, so interested participants should inquire further.

Inclusion Criteria

I can do most of my daily activities by myself.

I am 18 years old or older.

My lung cancer is in an early stage and can be removed with surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive standard neoadjuvant therapy and undergo breath sampling at baseline and 2 weeks after therapy

2 weeks

2 visits (in-person)

Surgery

Participants undergo surgery and breath sampling 2 weeks after surgery

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness with breath and blood sampling every 6 months for 2 years

2 years

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Breathprinting

Trial Overview The study is testing a new 'E-Nose' technology that analyzes breath samples to track changes in chemicals before and after standard cancer treatment in NSCLC patients.

How Is the Trial Designed?

Group I: Cohort 2 (stage I NSCLC) Experimental Treatment 1 Intervention

10 patients who are planned to undergo upfront surgery will undergo breath sampling (1) at baseline before upfront surgery, (2) 2 weeks after surgery, (3) 6 months after surgery, and (4) every 6 months for the first 2 years.

Group II: Cohort 1 (stage II to IIIB NSCLC) Experimental Treatment 2 Interventions

40 patients undergoing neoadjuvant treatment (stages II to IIIB) will undergo breath sampling (1) at baseline before any treatment, (2) 2 weeks after neoadjuvant therapy, (3) 2 weeks after surgery, (4) 6 months after surgery, and (5) every 6 months for the first 2 years. Blood sample collections will coincide with the breath collection schedule.

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/PMC12238155/

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, ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)00125-5/fulltext

Lung cancer detection by electronic nose analysis ... Electronic nose (eNose) analysis of exhaled breath shows potential for accurate and timely lung cancer diagnosis.

3. jto.org jto.org/article/S1556-0864(24)00211-9/fulltext

A Real-World Assessment of Stage I Lung Cancer Through ... Therefore, the aim of our study was to assess the diagnostic performance of E-nose technology in clinical stage I lung cancer. Methods. This phase IIc trial ( ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0923753425001255

Lung cancer detection by electronic nose analysis of ... Electronic nose (eNose) analysis of exhaled breath shows potential for accurate and timely lung cancer diagnosis, yet prospective external validation ...

5. 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.

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

A Real-World Assessment of Stage I Lung Cancer Through ... Electronic nose (E-nose) technology has reported excellent sensitivity and specificity in the setting of lung cancer screening. However, the performance of ...

7. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-02840-z

Cross-site validation of lung cancer diagnosis by electronic ... Our study revealed that deep learning models developed for eNose breathprint can achieve cross-site validation with data augmentation and fine-tuning.