|SCREENING EQUIPMENT||• Uses the doctor’s / facility's||• AWBUS is an automated add-on to
the doctor’s / facility’s ultrasound
machine - not a replacement
• AWBUS assists the operator performing the procedure in systematically scanning and recording all breast tissue
|PROBE SIZE||• 5cm - Standard||• 5cm - Standard|
|PAIN CAUSED BY THE PROCEDURE||• The 5cm probe causes no pain during the exam||• The 5cm probe causes no pain during the exam|
|BREAST COVERAGE DURING SCANNING||• Depends on experience, expertise
& education of the tech/physician
• Inconsistent - varies person to person
• Concentration divided between good-enough scanning and detection
|• AWBUS program prevents skipped
areas on the surface and deepest
parts of the breast
• Concentration is focused solely on doing the best possible scan
|HOW IMAGES ARE GATHERED||• Gathering & viewing are done
simultaneously and, therefore, at
the same speed
• When gathered quickly, does not provide sufficient images for recognition of small lesion
• When gathered slowly does not allow for recognition of an aberrant disruption
• Very few permanent images gathered
|• Gathering and reviewing are
separated and therefore optimized
• Gathering is done slowly to collect sufficient images for quality interpretation
• Depending on breast size, 4,000-8,000 permanent images are gathered
|HOW IMAGES ARE VIEWED||• Large screen format while scanning in a distracting environment, not optimized for viewing||• Small screen format in a nondistracting environment
• Images are viewed as a ciné loop at an optimized speed (quickly) and size, enabling recognition by the maculae of aberrant disruptions
• Disruptions are detected as motion, for which the human eye is very sensitive
|AVERAGE DIAMETER OF CANCERS FOUND||Hand Scanning (Astound Study):
• 8% 5-10mm
• 33% 11-14mm
• 58% 15mm or larger
• About 75% less than 10mm
• About 15% 10-13mm
• About 10% 13mm or larger
• The mean for 3 major AWBUS sites is 8mm
|INTERPRETATION||On-line in exam room, patient can demand biopsy for any lesion found, even when a radiologist believes it to be benign||Off-line reading, a radiologist can call more lesions benign, and reduce false positive rates|
|MULTITASKING||• Scanning and detection are done simultaneously, preventing full needed attention to each task||• Scanning and detection are done separately, allowing full attention needed for each task|
|RECOGNITION OF PATHOLOGY||May be missed by:
• Distracted viewing
• Improperly large image
• Shorter persistence of the image due to fewer recorded images
• Imaging display factors set by the technologist
• Non-distracted viewing
• Proper sizing of the image
• Increased persistence of the image due to decreased distance between images
• Complete control of display factors of the images by the reading radiologist
|PERMANENT RECORD||No permanent recording of entire
• If abnormality not seen during scanning, it goes undetected
• Prevents off-site reading
• Only a verbal description and a few single images of a recognized abnormality can be archived
|Permanent recording of entire scan:
• Recordable to a CD or stick
• Easily reviewed by other physicians at a distance or even years later
• Allows off-site reading for radiologists, FPs, OBGYNs and breast surgeons
• All images transfer to PACS or other image archiving system
• The radiologist’s report is based on review of all possible findings in the breasts
|FINANCIAL IMPLICATIONS||• Possible loss of revenue from competing sites adopting AWBUS||• Will increase business and result in a net positive bottom line.|
|TRAINING||• Training to scan consistently the
entirety of both the breast at a
steady rate & steady pressure is
• Training someone to simultaneously scan well, recognize malignancy & know if any tissue has been missed is very difficult
|• AWBUS uses the radiologist’s
standard ultrasound machine and
format, and requires no additional
• AWBUS relieves the operator of determining probe speed & position, and recognition of malignancy all at the same time
• Training is almost entirely about capturing quality images by manipulating the pressure and incidence of the probe to the skin
|WORK FLOW||• The radiologist either sees fewer cases a day due to both acquiring and reading images, or relies on the skill and judgement of a nonphysician operator||• The radiologist either sees fewer cases a day due to both acquiring and reading images, or relies on the skill and judgement of a nonphysician operator|
|JOB FLEXIBILITY||• Inflexible: radiologists need to be present during patient exams||• Flexible: radiologists needn’t be present during exams, which can be read at their convenience (evenings, weekends, etc.)|
|PROPERTIES OF A GOOD SCREEN||• Not reproducible
• Every screen is variable, regardless of place, time or operator
• Every screen is the same, regardless of place, time or operator
SONOCINE vs. GE in Finding Invasive Cancer
- SonoCiné uses a standard 2” transducer, whereas GE uses a 6” transducer.
- The 6” transducer has to flatten the entire breast, causing the exam to range between somewhat uncomfortable to outright painful.
- The 2” transducer is entirely painless.
- The 6” transducer doesn’t cover all breast tissue. It can’t get into the armpit where the lymph nodes are and where the tail of the breast is, and can’t reach the top of the breast just beneath the collarbone. It also has difficulties with the lower part of the breast and near the breastbone.
- The 2” transducer reaches all of those areas – no breast tissue is left unseen.
- A 5mm cancer is 10% of the width of the image produced by the 2” transducer, and is easily seen because it appears relatively large in the image.
- A 5mm cancer is 3% of the width of the image produced by the 6” transducer, and is easily missed because it is so small in the image.
- Cancers found with the 6” transducer initially averaged 13mm, and are now about 11mm.
- Cancers found with the 2” transducer initially averaged 9mm, and now average 7mm, with many seen 3-5mm.
- Volume-wise, the initial cancer comparison of GE to SonoCiné was that GE’s cancers were 3x the volume.
- Volume-wise now, GE’s cancers are about 3.8x the volume of SonoCiné’s (almost 2 doublings).
- Although both SonoCiné and GE have improved results, GE has trouble seeing the smallest & easiest treated cancers, and therefore has not improved as much as SonoCiné.
- SonoCiné exams can be recorded to a CD or stick and played on any PC, and are therefore easily reviewed by consulting and referring physicians.
- GE exams are very large and cannot be transferred to PCs for review by any consulting or referring physician.
- Because of the large size of the GE file, it is difficult-to-impossible to transfer the study to another medical facility that also has the same GE machine.
- The large GE file size also slows down the PACS (the imaging archiving and retrieval system).
- SonoCiné’s smaller file size allows off-site reading by radiologists for FPs and OBGYNs with SonoCiné machines in their practices.
- GE’s large file size prevents off-site reading.
- The price of a SonoCiné machine is about ½ that of a GE.
- The examining room used by SonoCiné can be used for routine ultrasound examinations when breast screening is not being performed.
- The examination room used by GE can only perform screening breast exams. The room can’t even be used to do a confirmatory handheld ultrasound exam, so the patient needs to be moved to another room.
- The images produced by GE are non-standard-size ultrasound images, and therefore require training and experience to interpret well.
- SonoCiné uses the radiologists’ ultrasound machine and format, and requires no additional training.
- GE’s 6” transducer requires an extended field of view beyond the area of macular vision where we distinguish abnormal motion, the hallmark of screening ultrasound breast cancer detection.
- Because of SonoCiné’s 2” transducer the SonoCiné presents the entire motion to fall in the area of macular vision, our most acute vision, and thus increases the likelihood of detecting cancer.
- The GE ABUS images are devoid of sonographic information in the retroareolar area.
- SonoCiné AWBUS uses a proprietary nipple pad to facilitate visibility within and behind the nipple and areola.
- SonoCiné does not use 3-D. SonoCiné is a pure screening device. 3-D is a diagnostic tool and is for investigating a known mass (diagnosis)
- Diagnosis is done as a handheld examination with one’s own ultrasound machine using greyscale, Doppler and any other features available
- SonoCiné screens whole breasts and must do so:
- A) Rapidly as possible (2 to 5 min both breasts)
- B) With no missed tissue in the breast & lower axilla
- C) As conspicuously as possible:
- 3 – 10 mm cancers easily stand out in the ciné as ‘aberrant disruptions’
- GE does none of 31-34
- SonoCiné was designed over 15 by a breast radiologist with 30 years breast ultrasound reading experience, rather than by mechanical engineers with zero breast ultrasound reading experience.