Using e-Nose Technology to Identify Early Lung Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04734145

Collaborator

(none)

110

Enrollment

Locations

Anticipated Duration (Months)

15.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung; Node Lung Cancer	Diagnostic Test: Breathprinting test

Study Design

Study Type:

Observational

Anticipated Enrollment :

110 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Breathprinting (e-Nose) Technology for the Identification of Early-Stage Lung Cancer

Actual Study Start Date :

Jan 25, 2021

Anticipated Primary Completion Date :

Jan 25, 2023

Anticipated Study Completion Date :

Jan 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Participants with an Undiagnosed Pulmonary Nodule 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.	Diagnostic Test: Breathprinting test Consented, enrolled participants will undergo a breathprinting test (e-nose) during the presurgical visit and at the same facility as their presurgical or prebiopsy visit, before any attempt is made to obtain cytohistological diagnosis of the pulmonary nodule. Other Names: E-Nose

Arm

Intervention/Treatment

Participants with an Undiagnosed Pulmonary Nodule

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.

Diagnostic Test: Breathprinting test

Consented, enrolled participants will undergo a breathprinting test (e-nose) during the presurgical visit and at the same facility as their presurgical or prebiopsy visit, before any attempt is made to obtain cytohistological diagnosis of the pulmonary nodule.

Other Names:

E-Nose

Outcome Measures

Primary Outcome Measures

Disease status determined by e-nose testing [up to 1 month (time to biopsy)]
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 Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)
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
Patient must agree to undergo fine-needle aspiration biopsy, robotic bronchoscopy, and/or surgical resection for diagnosis prior to e-nose collection
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge (Consent only)	Basking Ridge	New Jersey	United States	07920
2	Memoral 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
5	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Study Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Consent Only)	Uniondale	New York	United States	11553