Clinical trial NCT04734145: Using e-Nose Technology to Identify Early Lung Cancer
Official title: Breathprinting (e-Nose) Technology for the Identification of Early-Stage Lung Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung; Node
Lung Cancer
Keywords: lung cancer
lung nodule
lung node
Memorial Sloan Kettering Caner Center
20-349
Breathprinting
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 119
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the principal investigator (PI), or the research team at MSK. If the PI is a member of the treatment team, he or she will screen his or her patients' medical records for suitable research study participants, and discuss the study and the patient's potential for enrolling in the research study with the patient. Potential subjects contacted by their treating physician will be referred to the PI/research staff to record appropriate contact information, so that these patients can be approached about enrolling in the study.

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 if the e-nose technology is more effective at diagnosing lung cancer if the tumor size is larger.


Eligibility criteria: 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)

Primary outcomes:
measure: Disease status determined by e-nose testing
timeFrame: up to 1 month (time to biopsy)
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Study Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gaetano Rocco, MD
role: PRINCIPAL_INVESTIGATOR
References: