Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma

NCT ID: NCT06037941

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-08
• Study Completion Date: 2026-09-30

Brief Summary

The researchers are doing this study to test the ability of a new technology called breathprinting, or electronic nose (E-Nose), to measure how people respond to standard treatment for malignant pleural mesothelioma (MPM). The researchers will study how E-Nose breathprints change over time as people receive standard treatment for MPM. They will also look at how changes in people's E-Nose breathprints compare to changes in their standard imaging scans and in biomarkers of MPM in their blood.

Conditions

Malignant Pleural Mesothelioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

E-Nose Technology

Patients undergo a breathprinting test (E-Nose) at baseline and at the first three standard of care follow-ups, as scheduled by their treating physician, that involve a CT of the Chest and/or PET/CT. The E-Nose testing will be administered by trained staff. Staff will use proper personal protective equipment during collections. Subjects will undergo E-Nose testing in a presurgical or interventional radiology suite. Subjects must consent to no smoking, no tooth brushing, and no food or drinks starting on midnight of the day of the E-Nose test. If fasting from midnight until the E-Nose test is not feasible, subjects may consent to fasting for 2 hours prior to each E-Nose test. Subjects opting to fast for 2 hours before each E-Nose test can only have still, non-carbonated water and non-aromatic foods or foods that do not develop aromatic compounds, such as low salt simple crackers, starting at midnight on the day of the E-Nose test until 2 hours before the collection.

Group Type: EXPERIMENTAL

E-Nose testing

Intervention Type: DIAGNOSTIC_TEST

At baseline (before any treatment is administered) approximately when the patient is scheduled for a CT of the Chest and/or PET/CT after initiation of any treatment, as medically permissible and at the PI's discretion. A breath sample from each patient will be captured in a cartridge, which will form the basis for the E-Nose analysis, to be performed by study investigators at UCB.

Research blood

Intervention Type: DIAGNOSTIC_TEST

Research blood tests will be obtained at baseline and the first three standard of care follow up visits, scheduled by their treating physician along with a CT of the Chest and/or PET/CT1 to determine whether serum biomarkers of MPM.

Interventions

E-Nose testing

At baseline (before any treatment is administered) approximately when the patient is scheduled for a CT of the Chest and/or PET/CT after initiation of any treatment, as medically permissible and at the PI's discretion. A breath sample from each patient will be captured in a cartridge, which will form the basis for the E-Nose analysis, to be performed by study investigators at UCB.

Intervention Type: DIAGNOSTIC_TEST

Research blood

Research blood tests will be obtained at baseline and the first three standard of care follow up visits, scheduled by their treating physician along with a CT of the Chest and/or PET/CT1 to determine whether serum biomarkers of MPM.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Aged 30-85 years
• No history of thoracic cancer or extrathoracic cancer potentially involving pleural metastases (i.e., breast, gastric, colon, or pancreas cancer)
• Recent diagnosis of MPM
• Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study, and signed standard surgical consent for surgical resection

Exclusion Criteria

• Aged <30 or >85 years at the first outpatient visit
• History of thoracic or extrathoracic cancer that puts the subject at risk for pleural or pulmonary metastases

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNIVERSITY CAMPUS BIO-MEDICO, ITALY

UNKNOWN

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaetano Rocco, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Bergen (Consent Only )

Montvale, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only)

Commack, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gaetano Rocco, MD

Role: CONTACT

roccog@mskcc.org

212-639-3478

David Jones, MD

Role: CONTACT

212-639-6428

Facility Contacts

Gaetano Rocco, MD

Role: primary

212-639-3478

Gaetano Rocco, MD

Role: primary

212-639-3478

Gaetano Rocco, MD

Role: primary

212-639-3478

Gaetano Rocco, MD

Role: primary

212-639-3478

Gaetano Rocco, MD

Role: primary

212-639-3478

Gaetano Rocco, MD

Role: primary

212-639-3478

Gaetano Rocco, MD

Role: primary

212-639-3478

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

23-100

Identifier Type: -

Identifier Source: org_study_id