Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma
- Conditions
- Malignant Pleural Mesothelioma
- Interventions
- Diagnostic Test: E-Nose testingDiagnostic Test: Research blood
- Registration Number
- NCT06037941
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description E-Nose Technology E-Nose testing 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. E-Nose Technology Research blood 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.
- Primary Outcome Measures
Name Time Method Change of MPMspecific VOCs up to 1 year compared with imaging (using RECIST 1.1 and mRECIST).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
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 Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Nassau (Consent Only)
🇺🇸Uniondale, New York, United States
Memorial Sloan Kettering Basking Ridge (Consent Only)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent Only)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent Only )
🇺🇸Montvale, New Jersey, United States