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E-Nose Breathprint Testing for Mesothelioma

N/A

Recruiting

Led By Gaetano Rocco, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 30-85 years

No history of thoracic cancer or extrathoracic cancer potentially involving pleural metastases (i.e., breast, gastric, colon, or pancreas cancer)

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new tech (E-Nose) to see how people respond to standard treatment for mesothelioma. It will measure changes in E-Nose breathprints, imaging scans & biomarkers in blood.

Who is the study for?

This trial is for adults aged 30-85 who have recently been diagnosed with malignant pleural mesothelioma (MPM) and haven't had thoracic cancer or cancers like breast, gastric, colon, or pancreas that could spread to the chest. Participants must consent to all study procedures.

What is being tested?

The study is testing E-Nose technology which analyzes breathprints to see how well patients respond to standard MPM treatments. It compares these breathprints over time with imaging scans and blood biomarkers related to MPM.

What are the potential side effects?

Since this trial involves non-invasive E-Nose testing and research blood tests rather than drug interventions, side effects are minimal but may include discomfort from the breathing test or bruising from blood draws.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 30 and 85 years old.

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I have never had cancer in my chest or cancer from the breast, stomach, colon, or pancreas that has spread to the lining of my lungs.

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I have recently been diagnosed with mesothelioma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am either younger than 30 or older than 85.

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I have a history of cancer that could spread to my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of MPMspecific VOCs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: E-Nose TechnologyExperimental Treatment2 Interventions

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.

0 / 5Eligibility criteria met