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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Malignant Pleural Mesothelioma

Treatments: Diagnostic Test: E-Nose testing; Diagnostic Test: Research blood

Study type: Interventional

Funder types: Other

Identifiers

NCT06037941

23-100

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

E-Nose Technology

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Research blood

Diagnostic Test: E-Nose testing