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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06037941

Collaborator

UNIVERSITY CAMPUS BIO-MEDICO, ITALY (Other)

Enrollment

Locations

Arm

23.8

Anticipated Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Pleural Mesothelioma	Diagnostic Test: E-Nose testing Diagnostic Test: Research blood	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Sep 8, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: E-Nose Technology Patients will undergo E-Nose testing at baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). Patients will undergo E-Nose testing in a presurgical or interventional radiology suite.	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. Diagnostic Test: Research blood Research blood tests will be obtained at baseline, 1, 3, and 6 months post-treatment to determine whether serum biomarkers of MPM.

Arm

Intervention/Treatment

Experimental: E-Nose Technology

Patients will undergo E-Nose testing at baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). Patients will undergo E-Nose testing in a presurgical or interventional radiology suite.

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.

Diagnostic Test: Research blood

Research blood tests will be obtained at baseline, 1, 3, and 6 months post-treatment to determine whether serum biomarkers of MPM.

Outcome Measures

Primary Outcome Measures

Change of MPMspecific VOCs [up to 1 year]
compared with imaging (using RECIST 1.1).

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge (Consent Only)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Consent Only)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Consent Only )	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (Consent Only)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Consent Only)	Uniondale	New York	United States	11553