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

Malignant Pleural Mesothelioma Clinical Trial

Official title:

Breathprinting (E-Nose) Technology to Measure Response to Treatment of Malignant Pleural Mesothelioma (MPM) Through MPM-Specific Volatile Organic Compounds Detected in Exhalates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037941
• Other study ID #: 23-100
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Gaetano Rocco, MD
• Phone: 212-639-3478
• Email: roccog[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma
• Mesothelioma, Malignant

Intervention

Diagnostic Test:
• E-Nose testing
At baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). 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
Research blood tests will be obtained at baseline, 1, 3, and 6 months post-treatment to determine whether serum biomarkers of MPM.

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 Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent Only)	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	UNIVERSITY CAMPUS BIO-MEDICO, ITALY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of MPMspecific VOCs	compared with imaging (using RECIST 1.1).	up to 1 year

External Links

•   Memorial Sloan Kettering Cancer Center