Using e-Nose Technology to Identify Early Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04734145
• Other study ID #: 20-349
• Status: Active, not recruiting
• Start date: January 25, 2021
• Est. completion date: January 25, 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: January 25, 2025
• Est. primary completion date: January 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Lung; Node

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent only )	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Study Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent Only)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease status determined by e-nose testing	For each study participant, disease status will be determined by e-nose testing ("cancer" or "no cancer") and by TTNA or surgery ("true" status).	up to 1 month (time to biopsy)

External Links

•   Memorial Sloan Kettering Cancer Center