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  ¤ý Computed Tomography Laser Mammography - Catalogue 1
   
  TECHNICAL DESCRIPTION
   
  CTLM IS A REVOLUTIONARY NEW LASER IMAGING MODALITY. IT HAS BEEN DESIGNED

TO IMPROVE BREAST CANCER DETECTION METHODS AND TO BE AN ADJUNCT TO

MAMMOGRAPHY TO HELP REDUCE THE NUMBER OF NEGATIVE BREAST BIOPSIES.

  ¤ýTHE CLINICAL PROBLEM
  Many of these missed lesions will subsequently be picked up by other imaging techniques, or by follow-up mammography. However,
it is very important to note that the mammogram, no matter how good its quality, does not contain all of the necessary
information for many radiologists, (no matter how expert), to say whether the abnormality detected is a cancer,
requiring surgery, or a benign lesion which can just be followed by imaging.

Therefore, in order to avoid missing a cancer, the mammographer advises biopsy on many lesions which later turn out to be
benign (up to 80%). Thousands of women sustain great emotional and/or physical trauma, removal of breast tissue, and
considerable expense only to prove that the mammographic finding was a ¡°False Positive¡±.

   
  THE CTLM SOLUTION
  The high percentage of false positive biopsies also presents a substantial cost to the health care system. Reducing false
positive biopsies therefore, can have a favorable effect on managing breast cancer detection and staging. The CTLM¢ç may
be an optimal tool to address these needs and opportunities.
   
  CTLM¢ç CT Laser Mammography System
  ¤ýCLINICAL APPLICATION
  The CT Laser Mammography system (CTLM¢ç) system is intended for use as an adjunct to mammography in patients who have indeterminatemammographic findings particularly in dense breasts. It is not intended for use in cases with clear mammographic or non-mammographic
indications for biopsy.

This device provides the radiologist with additional information to decide whether a biopsy is necessary.Many countries have approved the CTLM, although it is not yet approved for sale in the USA.
   
 
BENEFITS UNIQUE CTLM DESIGN
¤ý Leading-edge CT molecular imaging study
The CTLM functions somewhat like a conventional CTScanner in that an energy source (NIR Laser) scansaround the breast and a computer reconstructscross-sectional images based on measured optical data.The measured optical values are directly related to theoptical effective transport coefficient of the breast tissue.Like CT, the images may be viewed as single slices or as 3D volumes.
¤ýNo ionizing radiation (no X-ray)
¤ý Helps eliminate unnecessary biopsies
¤ýComplements conventional mammography
¤ý Works well with dense breasts
¤ý Non-invasive/Comfortable
¤ýNo breast compression (no pain)
¤ý Easy and inexpensive to operate
¤ýHigh throughput

The Food and Drug Administration has deemed the CT Laser Mammography System as a Non-Significant Risk Device (NSR). Therefore, it does not present the potential
for serious risk to the health, safety or
welfare of the patient.
The patient lies face down in a comfortable position, with the breast to be examined suspended through a circular aperature in the tabletop (Fig. 1A/B). Nothing touches the breast; there is no compression, and, even more important, there is no X-irradiation, because we replaced the X-ray tube with a laser. The laser beam is not strong enough to even warm the skin and, by choosing the right wavelength, the beam passes right through large and dense breasts.
 
Figure 1A: Breast in scanning position   Figure 1B: Laser scanning electronics

Detectors are arrayed around the breast (¡°CT-like¡± design)
 
THE THEORY OF CT LASER SCANNING IN CLINICAL PRACTICE
Figure 2: Absorption of light (vertical axis) in hemoglobin, water, and fat, at various wavelengths (horizontal axis). CTLM uses a wavelength of 808 nm at which point oxy and
deoxyhemoglobin both absorb the near infrared light but water and fat absorb virtually none.
 
Figure 3B: Cranio-caudal CTLM shows a very large volume of angiogenesis (redarrows) and new vessels growing in from the chest wall (blue arrows). Tumor size 3.0mm, angiogenesis size 6.0cms.Angiogenesis extends across the breast where the tumor has involved the skin (double red arrows).

Our approach is based on the fact that all cancers must develop a blood supply of their own in order to survive. In fact, a cancer can not grow beyond 2.0 mm in size without this new blood supply, called ¡®angiogenesis¡¯. The CTLM system images the angiogenesis by detecting the presence of increased

hemoglobin in the imaging field. Since the area of angiogenesis is much larger than the tumor itself, tumors which are invisible or barely visible on the mammogram can be detected.

Images are not as sharp and crisp as seen on CT or Mammography, but have the character of Nuclear Medicine results because the angiogenesis process is diffuse.

CTLM is,therefore, a ¡®functional¡¯ imaging modality with the potential to perform molecular imaging.
Figure 2: Absorption of light (vertical axis) in hemoglobin, water, and fat, at various wavelengths (horizontal axis).
CTLM uses a wavelength of 808 nm at which point oxy and deoxyhemoglobin both absorb the near infrared light but water and fatabsorb virtually none.
CTLM¢ç CT Laser Mammography System
¤ýCTLM AND MRI FUSION
 
Figure 4A: MRI of the breast showing a bilobed area of angiogenesis. One of the lobes shows very little angiogenesis.   Figure 4C: Fusion of the MRI and CTLM images
shows that the CTLM and MRI demonstrate the
same angiogenesis. Red arrow...malignant phylloides tumor...Blue arrow, fibroadenoma.
 
Figure 4B: CTLM of the same breast in the same projection also shows bilobed angiogenesis with one lobe showing little angiogenesis.   CTLM is much quicker than MRI, cheaper, and uses no contrast media injection
 
CTLM 3D IMAGING
CTLM images can be collected in true CT fashion and, displayed as CT sections or as a true 3D image, rotatable in space (Figs. 5 and 6).
  CTLM STANDARD VIEWS
 
Figure 5: Maximum Intensity Projection (MIP)
The arrowheads mark a large volume of angiogenesis. The short arrows indicate normal ¡°tubular¡± veins.
  Figure 7: Sagittal, Coronal and Axial Planes
This is the standard four view image presented on
the reading console...coronal, sagittal, axial, and
three dimensional images. The white lines indicate
intense angiogenesis in an invasive ductal cancer.
    CTLM SIDE-BY-SIDE MAMMO/CTLM DISPLAY
 
Figure 6: Surface-Rendered FTB Projection
This is the same case as Figure 5. The morphology of the angiogenesis is better demonstrated by this ¡°one click¡± function.
  Figure 8: The Cranio-caudal mammogram shows
three lesions. The CTLM shows angiogenesis in only one of them (long arrow), the other lesions (circle) are benign.
FULL CTLM DISPLAY WITH FTB   FTB AND MAMMO FUSION
 
Figure 9A: Surface rendering Front-To-Back (FTB) projection of Figure 4.   Figure 10: The FTB image has been merged with the
cranio-caudal mammogram. The original 3.0 lesion is at the tip of the white arrow. The angiogenesis extends across the breast and there is involvement of the skin (double red arrows). Blue arrows show new vessels arising from the chest wall.
     
  IMAGE QUALITY
In-vitro studies of imaging phantoms provide objective
performance quantifications:
Object Detectability - The CTLM clearly resolves a
1¡¾ 0.2 mm spherical opaque inclusion suspended in a 110mm diameter circular phantom of standard IntraLipid solution,
with the inclusion 20mm (radially) from the bucket wall.
Field Uniformity - The CTLM clearly resolves a 1.0¡¾
0.2mm spherical opaque inclusion suspended in a
110 x 80mm elliptical phantom of standard IntraLipid
solution, with the inclusion 20mm (radially) from the
bucket wall at the 12:00, 3:00, 6:00 and 9:00 positions.
SCANNER
Figure 9B: This is a 3D ¡°surface-rendered¡±, (FTB), image of the case in Figure 3B. This reconstruction reveals more clearly the extent and structure of the angiogenesis. FTB projection gives an excellent presentation of the numerous small vessels associated with this tumor.  

Scan Field of View - The scanner acquires data from a 200mm diameter by 200mm tall right cylindrical field
of view.

Laser Beam Characteristics - The laser source beam
diameter is 3mm ¡¾20% through the scanning well. The average power delivered to the patient does not exceed 500mW. The wavelength is nominally 808 nanometers. Polarization is random.

FTB reconstruction provides a dramatic 3D solid representation of structures, normal and abnormal, within the breast and can be of great diagnostic value, particularly for displaying areas which are doubtful and/or
difficult to see on the standard MIP projection.
   
     
     
   
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