Status:
ACTIVE_NOT_RECRUITING
Using e-Nose Technology to Identify Early Lung Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Lung; Node
Lung Cancer
Eligibility:
All Genders
21-85 years
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 25 2026
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04734145
Start Date
January 25 2021
End Date
January 25 2026
Last Update
May 16 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, United States, 11725