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

NCT06037941 | Recruiting

• 1 other identifier: 23-100
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

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.

Conditions

Malignant Pleural Mesothelioma

Keywords

Breathprinting (E-Nose) Technology; MPM-Specific Volatile Organic Compounds; 23-100

Outcome Measures

Primary Outcomes (1)

• Change of MPMspecific VOCs

  compared with imaging (using RECIST 1.1 and mRECIST).

  up to 1 year

Study Arms (1)

E-Nose Technology

EXPERIMENTAL

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.

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

Interventions

E-Nose testing DIAGNOSTIC_TEST

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.

E-Nose Technology

Research blood DIAGNOSTIC_TEST

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.

E-Nose Technology

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• UNIVERSITY CAMPUS BIO-MEDICO, ITALY: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Consent Only )

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gaetano Rocco, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano Rocco, MD

CONTACT

212-639-3478; roccog@mskcc.org

David Jones, MD

CONTACT

212-639-6428

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: September 8, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (7)