Malignant Pleural MesotheliomaNCT06037941
Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma
A study testing E-Nose testing and Research blood in people with Malignant Pleural Mesothelioma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- E-Nose testing and Research blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Sep 2023to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
David Jones, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only)
Commack, New York, 11725
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only )
Montvale, New Jersey, 07645
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553
Gaetano Rocco, MD, 212-639-3478
About this study
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
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
- Being tested
- E-Nose testing, Research blood
- Keywords
- Breathprinting (E-Nose) Technology, MPM-Specific Volatile Organic Compounds, 23-100
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Nose testingDiagnostic 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 bloodDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: E-Nose testing; Diagnostic Test: Research blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MPMspecific VOCs
compared with imaging (using RECIST 1.1 and mRECIST).
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start8 Sep 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- UNIVERSITY CAMPUS BIO-MEDICO, ITALY
- Responsible party
- Sponsor
- Investigators
- Gaetano Rocco, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037941
- Sponsor's protocol ID
- 23-100
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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