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Human Clinical Trials 2008

Objectives

  1. Demonstrate that it is possible to detect breast cancer, prostate cancer and carotid artery disease using Flash Ultrasound™
  2. Demonstrate attribute analysis using Flash Ultrasound™

Protocol

  1. Using Flash Ultrasound™, patients with known cancer (breast & prostate) and disease (carotid & prostate) were imaged.
  2. The Flash Ultrasound™ dataset was then post-processed to determine data attributes that could be used to differentiate the cancerous or diseased tissue from normal.
  3. 30 patients from each cohort (breast, carotid, prostate)
  4. All studies were performed in the United Kingdom at facilities within the United Bristol Healthcare Trust and North Bristol NHS Trust

Breast patient - #201, Tissue Attributes Flash Ultrasound™

Demonstrates higher resolution @ lower frequency … visible micro calcification.
  • The patient has a confirmed breast tumor, Depth 4cm
  • The tumor boundaries are well defined, with high contrast between the tumor and the surrounding host tissue
The following images represent different attributes of the same region but analyzed and represented by different wave properties
These attribute displays are visually dynamic, enabling diagnostic capability.

Carotid Artery - Imaged with Flash Ultrasound™

This data set represents a comparison between Flash Ultrasound™ using virtual point sources to image a carotid artery and a similar image from a Phillips machine that is especially designed for such imaging and is using a 15 MHz transducer (a frequency 3 times higher than the 5 MHz used by Flash Ultrasound™ for its image).
The Philips uses harmonic imaging and proprietary filters to give it its basic look and feel (from Phillips marketing material).
It should be evident that the Flash Ultrasound™ image may have comparable spatial resolution at less than half the frequency.

Flash Ultrasound™ capabilities demonstrated in clinical settings

  • Identification of tumors and cysts
  • Differentiation of tumor boundaries
  • Differentiation of normal tissues and abnormal tissues
  • Demonstration of high spatial and contrast resolution at depth with low frequencies
  1. Sensitivity & Specificity
  2. Ultra-high spatial & contrast resolution
  3. Volumetric Information
  4. Tissue differentiation
  5. Adaptability