Clinical trial · Observational
Using e-Nose Technology to Identify Early Lung Cancer
Breathprinting (e-Nose) Technology for the Identification of Early-Stage Lung Cancer
NCT04734145CI-TRIAL-00110644active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. Additionally, researchers also want to see if the e-nose technology is more effective at diagnosing lung cancer if the tumor size is larger.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung; Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breathprinting test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with an Undiagnosed Pulmonary Nodule
- description
- 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.
- interventionNames
- Diagnostic Test: Breathprinting test
Primary outcomes (1)
- measure
- Disease status determined by e-nose testing
- timeFrame
- up to 1 month (time to biopsy)
- description
- For each study participant, disease status will be determined by e-nose testing ("cancer" or "no cancer") and by TTNA or surgery ("true" status).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age 21-85 * Single, monolateral nodule of at least 50% solid composition visible on chest CT scan (with or without contrast) suspicious for lung cancer. * 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) o Patients with biopsy-proven early stage, primary lung cancer that meets staging requirements, do not need to also have a radiology report meeting inclusion criteria * 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). * Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study o Patient must agree to undergo fine-needle aspiration biopsy, robotic bronchoscopy, and/or surgical resection for diagnosis prior to e-nose collectionNote: Biopsy-proven patients that meet eligible staging criteria who are not further surgical candidates will be collected prior to next step in standard of care treatment * Patients with biopsy-proven clinical stage I lung cancer are eligible if the biopsy is done within 6 weeks of the consent date Exclusion Criteria: * Age \<21 and \>85 years at first outpatient visit. * Multiple ipsilateral or bilateral nodules reported on chest CT scan and/or concurrent as suspicious for lung cancer (note: nodules deemed indeterminate, inflammatory, etc. will not exclude a patient from participating in this study) semisolid GGOs. * Lung nodule of interest is less than 50% solid in composition * Per MSK radiologist report or read, the lung nodule of interest is "less likely" or "unlikely" (i.e. less than 50% certainty) to be neoplastic (in accordance with the level of certainty criteria set forth by MSKCC Radiology) * Any previous history of lung cancer * History of any non-lung cancer(s) that is currently being treated (note: prior history of completely treated non-lung cancer from any time will be eligible) * Metastatic lung cancer disease seen on chest CT or PET scan at hilar/mediastinal nodes or contralateral lung or extrathoracic sites. * Previous medical history of a lung biopsy/surgical procedure for cancer diagnosis (note: patients who underwent a lung biopsy over three years ago that showed negative for lung cancer and patients who underwent a lung biopsy confirming stage I lung cancer within the past 6 weeks will be eligible)
References
Publications (1)
- DERIVEDRocco G, Pennazza G, Tan KS, Vanstraelen S, Santonico M, Corba RJ, Park BJ, Sihag S, Bott MJ, Crucitti P, Isbell JM, Ginsberg MS, Weiss H, Incalzi RA, Finamore P, Longo F, Zompanti A, Grasso S, Solomon SB, Vincent A, McKnight A, Cirelli M, Voli C, Kelly S, Merone M, Molena D, Gray K, Huang J, Rusch VW, Bains MS, Downey RJ, Adusumilli PS, Jones DR. A Real-World Assessment of Stage I Lung Cancer Through Electronic Nose Technology. J Thorac Oncol. 2024 Sep;19(9):1272-1283. doi: 10.1016/j.jtho.2024.05.006. Epub 2024 May 16. PMID 38762120