Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma
Breathprinting (E-Nose) Technology to Measure Response to Treatment of Malignant Pleural Mesothelioma (MPM) Through MPM-Specific Volatile Organic Compounds Detected in Exhalates
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Jones, MD
- Phone Number: 212-639-6428
Study Contact Backup
- Name: Gaetano Rocco, MD
- Phone Number: 212-639-3478
- Email: roccog@mskcc.org
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge (Consent Only)
-
Contact:
- Gaetano Rocco, MD
- Phone Number: 212-639-3478
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth (Consent Only)
-
Contact:
- Gaetano Rocco, MD
- Phone Number: 212-639-3478
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen (Consent Only )
-
Contact:
- Gaetano Rocco, MD
- Phone Number: 212-639-3478
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only)
-
Contact:
- Gaetano Rocco, MD
- Phone Number: 212-639-3478
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester (Consent Only)
-
Contact:
- Gaetano Rocco, MD
- Phone Number: 212-639-3478
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
Contact:
- Gaetano Rocco, MD
- Phone Number: 212-639-3478
-
Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau (Consent Only)
-
Contact:
- Gaetano Rocco, MD
- Phone Number: 212-639-3478
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
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 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of MPMspecific VOCs
Time Frame: up to 1 year
|
compared with imaging (using RECIST 1.1 and mRECIST). |
up to 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Gaetano Rocco, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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