Breast Biopsy with Breast CT

Diagnosing Breast Cancer

The only way to officially diagnose breast cancer is by pathology testing of a biopsy sample. It is important to understand the common imaging and diagnostic care paths that lead to a breast biopsy procedure and how they are performed. Inefficiencies are evident.

When a patient presents with a symptomatic breast or an abnormality is detected on a screening mammogram, a diagnostic mammogram is often performed by a radiologist who will take additional 2D images at different viewpoints to assess the shape and structure of the abnormality. If further investigation is required after the diagnostic mammogram, a patient may then have a breast ultrasound to determine if the abnormality is a fluid-filled cyst or a solid tumor, which may or may not be cancerous. After these diagnostic tests, a biopsy may be performed which is often ultrasound guided, though it is also common for patients to have even more imaging tests including additional diagnostic mammography, tomosynthesis or MRI imaging procedures, before that ultrasound guided biopsy is performed. In some cases, an abnormality may be best imaged on an MRI, in which case MRI would be used to guide the biopsy procedure. MRI requires a patient to be submerged 9ft into an imaging tube and this distance means a doctor cannot access the patient to perform a biopsy procedure and the patient must be brought out of the tube and imaged an additional 2-3 times to ensure that 1) the abnormality is properly located, 2) a plastic needle biopsy placeholder has been correctly positioned, and 3) that the needle itself has successfully sampled the suspicious lesion or tumor. The only way to definitively diagnose breast cancer is to perform a biopsy for pathology testing.

Izotropic Breast CT Biopsy System

In Q2 2020, The United States Patent and Trademark Office issued U. S. Patent No. 11/913494, entitled “Biopsy Systems For Breast Computed Tomography” to Izotropic Corporation.

The Izotropic Breast CT Biopsy System takes advantage of true 3D imaging capabilities comparable to MRI and would allow a suspicious lesion or tumor to be located in three dimensions during a diagnostic test and then immediately biopsied. This would reduce the timeline to diagnosis and minimize or eliminate additional imaging tests and medical appointments required to diagnose breast cancer. This may also decrease costly follow-up appointments and false-positive biopsy results. These false positives are where a suspicious lesion or tumor found on breast imaging that was thought to be cancerous was then determined to be benign after pathology testing of a biopsy sample.

A recent study found that the costs of follow-up imaging and diagnostic procedures after screening mammography in the US alone was over $8B USD annually.