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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: E-Nose TechnologyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change of MPMspecific VOCs

compared with imaging (using RECIST 1.1 and mRECIST).

Time frame
up to 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

UNIVERSITY CAMPUS BIO-MEDICO, ITALY

Collaborator