Can SureTouch be used as a diagnostic tool?
How does SureTouch compete with other breast exam machines or techniques?
What happens if an examiner comes to a false diagnosis with SureTouch? What legal risks may exist?
How does SureTouch work with the fibrocystic Breast?
Is SureTouch able to identify calcifications?
What about detection of micro-califications or Ductal carcinoma in situ (DCIS)?
Can I use the hardness levels to benchmark the difference between malignant or benign cancers?
It is not a diagnostic product. SureTouch is used to visualize the sense of touch, and generate an objective, accurate, and consistent printed report for review by the patient. A second formatted report is for review by the attending medical practitioner, and can be placed in the patient file as needed. A digital report file that can also be generated and be appended to the patient's electronic medical record viewable by mammographers and attending breast surgeons.
It does not, since SureTouch is not a diagnostic product. SureTouch enhances the current clinical process by providing a new functionality that does not currently exist, it electronically documents the CBE in a reproducible format.
SureTouch is NOT classified as a diagnostic device. It is more likely that SureTouch will protect a medical professional against potential lawsuits by discovering and locating a potential issue, and referring the abnormality and the abnormalities locations to the diagnostic level.
The problem with fibrocystic change/mastopathy is that the clinical exam demonstrates a palpable area which is more firm than the surrounding area. Since SureTouch translates the physical exam into a digital image, it will also demonstrate this palpable finding.
The differential between fibrocystic change/mastopathy and breast cancer is often a matter of firmness. SureTouch can differentiate between the level of firmness of the two. However, some cancers are not very firm and some fibrocystic change/mastopathy is fairly firm. SureTouch is not a diagnostic device to aid the decision as to the need for biopsy. It is, however, a way to finely differentiate between "firm" and "firm." A clinician may identify a palpable area and call it "firm" while the SureTouch can give you a numerical/visual value of the firmness.
In Dr. Kaufman’s paper in AJS, the area of most difficult distinction between cancer and non-cancer was in this group. Again, at this time SureTouch is a documentation device, and hopefully will be a diagnostic device, which might resolve this issue, soon. No SureTouch exam substitutes for a biopsy, as no physical exam (or mammogram/MRI/ultrasound) substitutes for a biopsy.
SureTouch does not identify calcifications, since they are not palpable. All the calcifications associated with cancer are not identified with SureTouch. Occasionally, a fibroadenoma may be calcified, and the fibroadenoma will be identified by SureTouch, simply identifying the palpable lesion, not the fact that it is calcified.
Physical examination does not usually find calcifications. Likewise, SureTouch is not able to identify calcifications. The only calcifications that it may identify are calcified fibroadenomas, or calcified hematomas, etc. In those cases, it is identifying the palpable lesion which happens to be calcified, not the calcifications themselves. Typical calcifications of DCIS are not identified with SureTouch. Only if the DCIS is a mass-forming DCIS does SureTouch have a chance at identifying it. Then again, it is the palpable findings that are being identified.
SureTouch translates the physical exam into a digital reproducible record. Those things that identify the physical exam (shape, size, firmness, consistency) are translated onto the screen. Shape and size are clear. Firmness of an area seen on SureTouch is a measure of the relative firmness of the target lesion relative to the surrounding breast tissue. There are no absolute figures that can be used to diagnose a lesion. Some hard lesions are cancers, cysts, and fibroadenomas. There may also be some softer cancers such as mucinous cancers, although these are still harder than surrounding breast tissue, but not as hard as the prior examples. So, in essence, the hardness measure is a guide as to how different the target lesion is relative to the normal breast tissue that surrounds it. In an older fatty replaced breast, a fibroadenoma might have a hardness scale of over 4, while the same fibroadenoma in a dense glandular breast might only have a 2.5 rating of hardness. In either case, the size, shape and increased hardness relative to the surrounding tissue will be consistent. Only the exact value of the hardness scale will not always be the same value.
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