Using e-Nose Technology to Identify Early Lung Cancer

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer; Lung; Node
• Intervention / Treatment: Diagnostic test: Breathprinting test

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

• Study Contact: Name: David Jones, MD; Phone Number: 212-639-6428; Email: jonesd2@mskcc.org
• Study Contact Backup: Name: Gaetano Rocco, MD; Phone Number: 212-639-3478; Email: roccog@mskcc.org

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge (Consent only)
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth (Consent only)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (Consent only )
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (Consent only)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Study Activities)
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau (Consent Only)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Gaetano Rocco, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Estimated): January 25, 2025
• Study Completion (Estimated): January 25, 2025

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: lung cancer; lung nodule; lung node; Memorial Sloan Kettering Caner Center; 20-349; Breathprinting
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 20-349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No