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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04734145
Other study ID # 20-349
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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