WO2000048515A1 - Technique non invasive de determination des dimensions d'une lesion - Google Patents

Technique non invasive de determination des dimensions d'une lesion

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Publication number
WO2000048515A1
WO2000048515A1 PCT/US2000/004218 US0004218W WO0048515A1 WO 2000048515 A1 WO2000048515 A1 WO 2000048515A1 US 0004218 W US0004218 W US 0004218W WO 0048515 A1 WO0048515 A1 WO 0048515A1
Authority
WO
WIPO (PCT)
Prior art keywords
lesion
holographic
imaging
soft tissue
image
Prior art date
Application number
PCT/US2000/004218
Other languages
English (en)
Other versions
WO2000048515A2 (fr
WO2000048515A8 (fr
Inventor
Barbara A. Fecht
Ronald L. Shelby
Jerod O. Shelby
Original Assignee
Advanced Diagnostics, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanced Diagnostics, Inc. filed Critical Advanced Diagnostics, Inc.
Priority to AU34962/00A priority Critical patent/AU3496200A/en
Priority to EP00913529A priority patent/EP1158902A1/fr
Priority to CA002399435A priority patent/CA2399435A1/fr
Publication of WO2000048515A1 publication Critical patent/WO2000048515A1/fr
Publication of WO2000048515A2 publication Critical patent/WO2000048515A2/fr
Publication of WO2000048515A8 publication Critical patent/WO2000048515A8/fr

Links

Definitions

  • the present invention provides a method for non-invasively determining dimensions of a lesion within soft tissue. Specifically, the present invention provides a transmissive ultrasound system having a holographic imaging detector. Background of the Invention
  • breast cancer screening techniques have been limited to mammography because screening techniques need to be economical in order to achieve widespread use.
  • mammography often has a high incidence of false positive readings that often prove to be benign or fluid- filled cysts that do not require surgical intervention or other highly invasive therapeutic procedures.
  • late-stage breast cancer detection is associated with significantly increased morbidity and mortality.
  • new diagnostic classification systems and improved detection methodologies there is still a great need to detect small neoplasms (typically 5 mm or smaller) accurately, quickly, non- invasively and inexpensively and with a good idea of size during the early detection process. Failure to detect such early breast cancers is associated with more invasive therapeutic interventions at higher risk and higher expense.
  • X-Ray mammography is the accepted standard screening tool for diagnosis of breast cancer. It has good resolution and clarity, is capable of detecting microcalcifications and sometimes delineates the borders of some masses. However, 60-80% of subsequent biopsies recommended from mammography result in benign diagnoses. Thus, there is a need in the art to improve the positive predictive value of conventional breast imaging. Mammography is also less sensitive for detecting cancers in women with mammographically dense breast tissue. Since the more dense, fibrous tissue can obscure neoplasms, mammograms are often inconclusive or inaccurate in these women. Thus, there is a need in the art to more accurately detect neoplasms in women with dense breasts.
  • mammography is an invasive procedure that should not be done too frequently in view of a cumulative effect of radiation doses. Many women are hesitant to be imaged because of a risk or even a perceived risk associated with exposures to radiation. Moreover, there is significant discomfort associated with a mammography procedure because the breasts have to under go significant compression that can also distort lesions, if present and flexible. Therefore, there are some significant shortcomings to mammography as a standard means for breast cancer screening.
  • X-Ray mammography One alternative to X-Ray mammography is conventional, reflective ultrasound using a pulse-echo technique.
  • breast sonograms using reflective ultrasound are used to characterize masses (such as whether they are cystic or solid) detected by physical exam or by mammography.
  • reflective ultrasound is operator- dependent, time-consuming, and a full image of the breast cannot be obtained or even stored for later reference.
  • sonography is not useful for the assessment or detection of microcalcifications, often the only sign of early in situ ductal carcinomas.
  • the present invention provides a method for non-invasively determining dimensions of a lesion within a soft tissue object, comprising:
  • the object is breast tissue.
  • the holographic planar image of a lesion in the first plane in step (b) uses all three axes to be orthogonal.
  • the apparatus contains a holographic detector element for imaging in an optical mode the distortions cause by transmissive acoustic through the soft tissue.
  • the means for z- axis measurement is to either determine numbers of planes traversed of a known thickness, or rotating the object (patient or body segment) such that the z-axis becomes a third dimension with an additional x-y axis measurement at about 90 degrees rotation, or both.
  • the present invention further provides a method for guiding a biopsy device in soft tissue to a lesion, comprising ultrasonically imaging the soft tissue in an apparatus having an acoustic transducer, an acoustic focussing system, a holographic imaging detector, and a means for visualizing the holographic image to simultaneously visualize both the biopsy device and the lesion site.
  • the apparatus contains a holographic detector element for imaging in an optical mode the distortions cause by transmissive acoustic through the soft tissue.
  • Figure 1 shows a schematic of the transmissive ultrasound apparatus used having a hologram detector element for visualizing the planar breast images.
  • Figure 2 shows four images of breast tissue using transmissive ultrasound with holographic detection.
  • the top two images show two views of a 2-3 cm infiltrating ductal carcinoma in a 38 year old female.
  • Transmissive ultrasound determined the size to be at least 2.3 cm with a portion of the lesion not included within the field of view.
  • Pathologic examination of the surgically-excised tumor revealed a 2.7 cm diameter invasive carcinoma.
  • the arrows show the lesion in each image.
  • the lower left image shows a 3-4 cm hypodense macrolobular carcinoma in a 44 year old female, as pointed by the arrow.
  • the lower right image shows a retroareolar carcinoma in a 50 year old female.
  • the size of this cancer was also predicted more accurately using transmissive ultrasound imaging.
  • Figure 3 shows comparative images of breast fibroadenomas using mammography (top left and bottom left), reflective ultrasound (top middle and bottom middle) and transmissive ultrasound with holography detection (called “optical sonography” and the top and bottom right images).
  • the row of top images is a 2 cm fibrotic mass in a 47 year old female. In comparing the images from the three modalities it could be best sized from the transmissive ultrasound image.
  • the bottom row is a 2-3 cm fibroadenoma in a 28 year old female. Again, it could be best delineated and could be best sized from the transmissive ultrasound image. In the mammography image, this lesion was not detected. However, in the case of this lesion, reflective ultrasound and transmissive ultrasound predicted the lesion of about the same dimensions.
  • Figure 4 shows comparative images of simple cysts using mammography (top left and bottom left), reflective ultrasound (top middle and bottom middle) and transmissive ultrasound with holography detection (called “optical sonography” and the top and bottom right images).
  • the row of top images are 1-2 cm complex and simple cysts in a 38 year old female. It should be noted that only the transmissive ultrasound showed the multiple cysts, whereas the mammography image shows, at most, two cysts. It is most clearly delineated from the transmissive ultrasound image, although all the modalities showed a broad size range of 1-2 cm in diameter.
  • the bottom row shows multiple 0.5 cm simple cysts in a 39 year old female. Again, it can be best delineated from the transmissive ultrasound image.
  • FIG. 5 shows in the top row of three images a 2 cm fibrotic mass in a 47 year old female comparing the three listed imaging modalities. Similarly, the bottom row shows a 2-3 cm f ⁇ broadenoma in a 28 year old female.
  • the present invention provides a method for non-invasively determining dimensions of a lesion within soft tissue, comprising:
  • the object is breast tissue.
  • the holographic planar image of a lesion in the first plane in step (b) uses all three axes to be orthogonal.
  • the apparatus contains a holographic detector element for imaging in an optical mode the distortions cause by transmissive acoustic through the soft tissue.
  • the means for z- axis measurement is to either determine numbers of planes traversed of a known thickness, or rotating the object (patient or body segment) such that the z-axis becomes a third dimension with an additional x-y axis measurement at about 90 degrees rotation, or both.
  • the present invention was made based upon comparison of data for breast screening comparing a transmissive ultrasonography process with holographic imaging to standard X- Ray mammography and, in some instances, standard reflective ultrasound in those breasts where some kind of a lesion was noted by either mammography or reflective ultrasound.
  • transmissive ultrasound with holography detection showed an ability of transmissive ultrasound with holography detection to accurately determine lesion size non-invasively in a manner surprisingly better than mammography or reflective ultrasound. This was confirmed in several cases by subsequent pathology analysis after surgical intervention (when warranted). The margins of lesions were particularly well-defined and provided substantial contrast to fatty and dense parenchyma.
  • the ability to determine tumor extent or lesion size of transmissive ultrasound with holographic detection also called acoustic holography
  • the present method of transmissive ultrasound was found to better guide biopsy devices (i.e., needles) through non-invasive, real time imaging of soft tissue.
  • Such information can also guide biopsy decisions, as well as literally guide a biopsy procedure in real time.
  • a three dimensional viewing technique to view the stacked images in a virtual reality environment.
  • One such technique for example, utilizes an ImmersadeskTM system (developed at the Electronic Visualization Laboratory of the University of Illinois at Chicago, www.evl.uic.edu/EVL/VR) for three dimensional image viewing (with appropriate stereo glasses).
  • the data for the 41 patient breast imaging study wherein breast tissue is a soft tissue, provided high resolution images from transmissive ultrasound with holography detection while overcoming some of the limitations of other imaging modalities (e.g., X-Ray mammography or reflective or pulse echo ultrasound).
  • Transmissive ultrasound with holography detection was able to differentiate gross as well as subtler variation among tissues and delineated the edges of breast structures, including cysts, ducts, fibroadenomas and cancers. It provides a whole breast field of view as well as acoustic zoom capabilities without loss of resolution.
  • the real-time feature is important for guiding invasive procedures, such as biopsy.
  • the transmissive ultrasound device used three large area (77.4 cm 2 ) transducers. Two source transducers illuminated the object and one reference transducer was mixed with the transmitted beam. All operated at the same fixed center frequencies with ultrasonic output equalized over a 600 kHz bandwidth.
  • the acoustic plane waves generated at the source transducers passed through the object (breast) creating a perturbed wave (altered through diffractions, reflections and refractions) which was received at the holographic detector apparatus.
  • the reference transducer operated at a frequency matching that of one of the source transducers and produced an unpreturbed plane wave, which was also received by the detector.
  • the interference pattern generated at the detector was illuminated with a laser and viewed using a CCD camera.
  • the raw image was displayed on a high-resolution monitor for real-time viewing.
  • patient interfaces There were three types of patient interfaces, which were interchangeable.
  • the object of interest was immersed in a water bath that allowed dynamic positioning and simultaneous palpation and manipulation by the clinician.
  • a second interface consisted of two water-filled bladders that were maintained in contact with the opposing sides of the object (breast) during imaging. Compression of the bladders against the breast was sufficient to hold the breast stable while contacting as much of the skin of the breast as possible to increase coupling area and the area viewed.
  • the transmissive ultrasonic imaging allowed for scanning through layers of the breast tissue (i.e., the z axis) by progressively moving the focal plane and for acoustic zooming of the field of view via acoustic lens adjustment.
  • the subjects were supported on a padded kneeling table that placed them in a semi-prone position. Baby oil was used as a skin-coupling agent.
  • the chest was lowered until the breast was positioned between two water-filled pillows. Compression of the pillows against the skin completed the coupling.
  • Scanning through the breast was completed by focusing from the lateral aspect of the breast to the medial aspect by acoustic lens adjustment.
  • the images were acquired and viewed in real time and stored by video sequences on tape and as still images (provided in the figures herein).
  • the study population consisted of 12 women with no lesions and 29 women with lesions. These lesions (confirmed by invasive means) included 25 masses (10 benign cysts, 10 fibroadenomas and 5 malignancies) and 4 calcification groups (3 benign and 1 representing ductal carcinoma in situ). Of the 12 women with no lesions, two had breast implants and two had ductal ectasia. Overall, the subjects' mammographic breast density was more dense than fatty, 81% demonstrated heterogeneously or extremely dense breast tissue, while 19% had scattered fibroglandular densities or almost entirely fatty breast tissue.
  • this technique was able to visualize clarity of ducts within the retroareolar complex and clear definition of the skin and subcutaneous tissue. Even in a patient with breast implants, compression to the breast and implant resulted in imaging the implant and surrounding breast tissue. The compression needed was much less than would have been needed for traditional mammography, a source of much patient discomfort.
  • the breast masses in the study population ranged in size from 4 mm to 5 cm with a mean of 1.8 cm.
  • Transmissive ultrasound with holographic detection found septations and high contrast margins characteristic of benign fibroadenomas.
  • Ten cysts were imaged wherein most were acoustically transparent (whiter gray level of display representing lower acoustical scattering) compared to adjacent breast tissue, but some appeared darker compared to surrounding tissue.
  • Mass 1 is a ductal infiltrating carcinoma (Figure 2 top)
  • mass 2 is a benign fibroadenoma ( Figure 3 bottom)
  • mass 3 is a cluster of benign cysts ( Figure 4 top).
  • the pathology of surgically excised tumors documented invasive ductal carcinoma for mass 1.
  • Mass 2 was diagnosed by histology from core needle biopsy samples.
  • Mass 3 was diagnosed by fine needle aspiration under ultrasound guidance and resulted in complete collapse of simple cysts.
  • Transmissive ultrasound with holographic detection requires an understanding of how to read the images displayed or recorded on various recording media.
  • the internal architecture of the malignant masses tended to be heterogeneous with darker gray level (higher acoustical scatter) overall.
  • the benign fibroadenomas tended to be homogeneously light centrally with dark rims (edge enhancements). Some of the dark rims were thin and well-defined while others were thick and microlobulated or indistinct. In most cases, cysts appeared relatively light internally (low scattering) with dark margins. However, there were cysts that appeared homogeneously darker compared with surrounding tissue. Larger microcalcifications were apparently detected on the transmissive ultrasound images corresponding to the same region in the breast on mammography.

Abstract

L'invention concerne une technique permettant de déterminer, de manière non invasive, les dimensions d'une lésion des tissus mous, consistant à (a) obtenir une image du tissu mou par imagerie ultrasonique dans un appareil pourvu d'un transducteur acoustique, d'un système de focalisation acoustique, d'un détecteur d'imagerie holographique, et d'un dispositif de visualisation de l'image holographique, (b) à obtenir une image holographique plane d'une lésion dans un premier plan ayant une épaisseur z, une dimension x traversant une large zone de la lésion et une longueur y le long de la lésion, x et y formant un angle d'environ 90 degrés, (c) à déterminer si l'image de la lésion est contenue dans différentes images planes, (d) à mesurer les dimensions x et y de la lésion dans le plan où la somme de x et y est maximale, et (e) à en déterminer la taille en trois dimensions à l'aide d'une mesure pour l'axe z.
PCT/US2000/004218 1999-02-19 2000-02-18 Technique non invasive de determination des dimensions d'une lesion WO2000048515A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU34962/00A AU3496200A (en) 1999-02-19 2000-02-18 Process for non-invasively determining the dimensions of a lesion
EP00913529A EP1158902A1 (fr) 1999-02-19 2000-02-18 Technique non invasive de determination des dimensions d'une lesion
CA002399435A CA2399435A1 (fr) 1999-02-19 2000-02-18 Technique non invasive de determination des dimensions d'une lesion

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12081999P 1999-02-19 1999-02-19
US60/120,819 1999-02-19

Publications (3)

Publication Number Publication Date
WO2000048515A1 true WO2000048515A1 (fr) 2000-08-24
WO2000048515A2 WO2000048515A2 (fr) 2000-08-24
WO2000048515A8 WO2000048515A8 (fr) 2001-03-15

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/004218 WO2000048515A2 (fr) 1999-02-19 2000-02-18 Technique non invasive de determination des dimensions d'une lesion

Country Status (4)

Country Link
EP (1) EP1158902A1 (fr)
AU (1) AU3496200A (fr)
CA (1) CA2399435A1 (fr)
WO (1) WO2000048515A2 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT201900025306A1 (it) * 2019-12-23 2021-06-23 Imedicals S R L Dispositivo e metodo per il monitoraggio di trattamenti hifu

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