Steven N. Hochwald, MD, MBA, FACS, Director of the Comprehensive Cancer Center and Chief of Surgical Oncology at Mount Sinai Medical Center, is a lead investigator on an international clinical trial that examines organic compounds in the breath to detect breast cancer.

In the United States, an estimated 249,260 new cases of breast cancer were diagnosed in 2018. The prognoses in patients with breast cancer depended mainly on the stage of the disease.

Early diagnosis and appropriate therapy can effectively reduce the mortality of breast cancer. There are several adjuvant screening methods (e.g., mammography, ultrasonography, digital breast tomosynthesis [DBT], and magnetic resonance imaging [MRI]) for breast cancer. However, the accuracy of these methods largely relies on the physicians’ experience, stage of disease, and the tumor’s histopathologic features. Therefore, there may be a misinterpretation or a missed diagnosis.

Furthermore, it is estimated that only 60% of women follow the established guidelines for breast cancer screening, with a large percentage of women choosing not to get screened. This is due to discomfort with the mammography, ultrasound, or MRI exam; lack of privacy; excessive cost; and inconvenience.

“Exhaled breath analysis has increasingly been adopted for early diagnosis of several disease states, including diabetes, explains Dr. Hochwald. “With the rapid development of exhaled breath metabolomics in recent years, the association between volatile organic compounds (VOCs) of exhaled breath and cancer has attracted increasing attention.”

Breath VOC analysis is appropriate for disease screening because it is noninvasive, portable, inexpensive, and easy for patients to accept. The technique also has the potential for early diagnosis.

The planned clinical trial will evaluate the exhaled breath of patients with precancerous conditions of the breast (carcinoma in situ) and those with biopsy-proven breast cancer and compare the presence and type of organic compounds in the breath to those patients who have normal mammography examinations and no evidence of breast cancer. Enough patients will be enrolled to determine if different breast cancer subtypes and whether the breast cancer stage at diagnosis correlates with specific signatures of organic compounds in the exhaled breath. The goal is to develop an exhaled breath test that can detect precancerous conditions of the breast as well as breast cancer type and stage.

The breath sample is collected in an aluminum bag, then processed by reducing the temperature to minus 20 degrees Celsius for at least three minutes, eliminating approximately 80% of the liquids. The bag is then processed using their aerosol generator, which generates droplets of 5 to 15 microns that go through the optical gas cell. The original detection is 200 parts per billion, but the company has managed to reduce it to one part per trillion.

Breath of Health’s machine is a standalone system and requires only electricity to perform its analysis of breath and delivery of results, meaning its services can be of great benefit to those in remote areas without access to hospitals with Mammography wings.