Breast CT vs Existing Modalities

Earlier Detection with Breast CT

The Izotropic Breast CT Imaging System is routinely imaging suspicious lesions and tumors in the 3-5mm range in ongoing clinical trials. The average size abnormality imaged using standard of care mammography is 11mm.

“If breast CT lives up to its enormous potential based on initial imaging breast cancer would be detectable far before metastases occurs – for example, a 3 mm tumor contains only 2% of the cell count of an 11 mm lesion, and a 5 mm lesion contains only 9% of the cell count. Based on a 100 day volume doubling time, detection of a 5 mm lesion would lead to 0.93 year earlier detection, and routine detection of 3 mm lesions would result in 1.5 year earlier detection over mammography.”
UC Davis Clinical Trial Overview

Advantages Over Existing Technologies

There is a significant unmet need for a breast imaging modality that is fast, affordable, and images the breast in true 3D. Clinicians cannot investigate or treat abnormalities that they cannot see.

“High resolution breast imaging is critical to identifying malignancies as early as possible. Izotropic’s Breast CT has the opportunity to offer patients, with or without dense breasts, a single rapid scan for breast cancer detection in complete comfort and dignity.” – Dr. John McGraw, Executive VP of Commercialization

Mammography is a 2D technology. Tomosynthesis, sometimes errantly referred to as 3D mammography, improves on this only slightly, by offering 15- 50 degree views depending on the brand. Both Mammography and Tomosynthesis require painful breast compression, which can obscure abnormalities or superimpose them resulting in false-negative and false-positive test results. While breast ultrasound examinations and MRI breast imaging provide 3D data sets, both are time intensive. This increased time translates into high cost. Neither ultrasound or breast MRI can identify micro-calcifications, a common early warning sign of breast cancer.

Icon Izotropic Large

Mammography

  • 2D Imaging
  • 15-30 Minute Exam Time
  • Requires Breast Compression
  • The gold standard for breast cancer screening
  • Misses 1 in 5 breast cancers due to false-negative test results
  • False positive results are common. About 50 percent of women who get annual mammograms over a 10-year period will have a false- positive finding at least once
  • May fail to detect inflammatory breast cancer, the deadliest form of breast cancer
  • Provides lower diagnostic accuracy and risks implant rupture in women with breast implants
  • Requires painful breast compression between 2 imaging plates and technologist handling of the woman’s breast. Compression can cause overlapping of the breast tissue in which abnormal tissue can be hidden and superimposed normal tissue can appear abnormal, resulting in false-negative and false-positive results

Tomosynthesis

  • 2D Imaging with 15- 50° views
  • 15-30 Minute Exam Time
  • Requires Breast Compression
  • Errantly referred to as “3D mammography”, in reality it is 2d mammography with a 15- 50° view depending on the brand of the machine
  • Typically used to investigate an abnormality found on a mammogram
  • Requires painful breast compression between 2 imaging plates and technologist handling of the woman’s breast. Compression can cause overlapping of the breast tissue in which abnormal tissue can be hidden and superimposed normal tissue can appear abnormal, resulting in false-negative and false-positive results

Ultrasound

  • 3D Imaging
  • 15-30 Minute Exam Time
  • No Compression
  • Painless and non-invasive imaging modality used to view internal structures of the breast
  • Primarily used to help detect/ diagnose abnormalities discovered on other modalities
  • Can help to determine if an abnormality is solid which may be a cancerous or non-cancerous lump, or fluid-filled such as a benign cyst

MRI

  • 3D Imaging
  • 45 Minute – 1.5 Hour Exam Time
  • No Compression
  • May be used for screening in woman who are “high risk”
  • Primarily used as a supplemental imaging tool to mammography and breast ultrasound
  • Used to further investigate an area after a new diagnosis of breast cancer
  • Further evaluating hard-to-assess abnormalities seen on mammography
  • Not applicable for claustrophobic patients
  • Expensive

Izotropic Breast CT Platform

  • True 3D Imaging with 360° Image Acquisition
  • Approx. 500 cross-sectional images 
  • 10 second exam time per breast
  • No Compression
  • Radiation dose comparable to Mammography
  • Imaging comparable to MRI
  • Images are viewable from multiple angles like a 3D model, or as individual cross-sectional image slices
  • Clinicians will have greater diagnostic capability to accurately determine size, shape and location of an abnormality with higher resolution imaging

Mammography

Patient A Mammography: In this standard two-view mammogram of a patient with breast implants, the cancer mass is obscured.

Izotropic Breast CT

Patient A Breast CT: The breast cancer mass and micro-calcifications present are clearly visible.