Παρασκευή 17 Φεβρουαρίου 2012

H Ψηφιακή Τομοσύνθεση Σώζει ζωές

Από πολυκεντρικές μελέτες που πραγματοποιήθηκαν διερευνήθηκε η αποδοτικότητα του συστήματος της Ψηφιακής Τομοσύνθεσης Ηologic Selenia Dimensions 3D και συγκρίθηκε η ικανότητα του ακτινολόγου στην ανίχνευση του καρκίνου με χρήση της 2D ψηφιακής μαστογραφίας σε συνδυασμό με την 3D, συγκριτικά με την χρήση μόνο της κλασικής 2D ψηφιακής μαστογραφίας. Στην Εικόνα 6 φαίνεται η καμπύλη ROC (καμπύλη ευαισθησίας και ειδικότητας) η οποία προέκυψε κατά μέσο όρο από 12 ανεξάρτητες καμπύλες ROC. Η μέση περιοχή κάτω από την καμπύλη ROC αυξήθηκε για τους ιατρούς διαγνώστες από 0.83 σε 0.90 χρησιμοποιώντας μια καταγραφή  BIRADS , σημειώνοντας δηλαδή αύξηση της τάξεως του 0.07, μια ιδιαίτερα σημαντική αύξηση με p-value ίσο με 0.0004. Χρησιμοποιώντας την μέθοδο 2D+3D έναντι της 2D μόνο , βελτιώθηκε η ευαισθησία από 66% σε 76% στις περιπτώσεις καρκίνων  BIRADS 4 και 5. Η ειδικότητα (specificity) σε βλάβες κατηγορίας BIRADS 1-3,  αυξήθηκε από 84% σε 89%. Τέλος, παρατηρήθηκε μία μέση μείωση 43% του ποσοστού επανάκλησης (ψευδώς αρνητικά).
                   

Μόνο ο Ψηφιακός Μαστογράφος Hologic Dimensions 3D 

διαθέτει FDA approval για εξετάσεις ΤΟΜΟΣΥΝΘΕΣΗΣ


RSNA 2011 - Key Scientific Tomosynthesis Presentations

There were several key scientific tomosynthesis presentations given at RSNA 2011 that add to the growing body of support for the benefits of tomosynthesis.  Below are highlights of five of the most relevant presentations.  The RSNA abstract for each is provided in a separate, attached document.

1.            Reading Time of FFDM and Tomosynthesis in a Population-based Screening Program; Skaane P, Gullien R, Eben E, Ekseth U, Haakenaasen U, Jahr G Jebsen I, Krager M;
                RSNA 2011, MSVB31-07 Breast Series: Emerging Technologies in Breast Imaging
               
Overview:          
The Oslo Screening Study will enroll 20K – 25K patients and will be an important study in terms of worldwide clinical acceptance and adoption of tomosynthesis.  Interim results were based on enrollment of 3,356 patients in the first 3 months of the study.  

Key Results and Conclusions:    
·        47% increase in cancer detection using tomosynthesis plus 2D imaging (8 cancers were missed in the FFDM arm and none were missed in the tomosynthesis arm)
·        Interpretation time for tomosynthesis is acceptable for high-volume mode screening

2.            Tomosynthesis During Baseline Examinations: Preliminary Assessment from a Prospective Screening Trial
                Gur D, Sumkin J, Zuley M, Anello M, Catullo V, Chough D, Cohen C, Ganott M, Hakim C, Hoffman W, Shah R, Shinde D
                RSNA 2011, MSVB31-08 Breast Series: Emerging Technologies in Breast Imaging
               
                Overview:
                Analysis of first 120 patients in ongoing, prospective study to evaluate the use of tomosynthesis during baseline screening in subjects between 39 and 56 years of age.  This study will continue, with a projected enrollment of 2,000 subjects.
               
Key Results and Conclusions:
·        28% reduction in recall rate with the use of FFDM plus tomosynthesis compared to FFDM alone
·        The use of tomosynthesis plus FFDM results in a substantial decrease in recall rates during baseline screening mammography of young women

3.            FFDM vs FFDm with Tomosynthesis for Women with Radiographically Dense Breasts: An Enriched Retrospective Reader Study
                Rafferty E, Niklason L
                RSNA 2011, MSVB31-10 Breast Series: Emerging Technologies in Breast Imaging
               
                Overview:
293 cases with BI-RADS density score of 3 or 4 were read retrospectively by 8 radiologists to evaluate the performance of tomosynthesis in dense breasts.

Key Results and Conclusions:
·        10% increase in recall rate for cancer cases with tomosynthesis plus 2D compared to 2D alone
·        31% reduction in recall rate for non-cancer cases with tomosynthesis plus 2D compared to 2D alone
·        Significant gain in diagnostic accuracy (ROC performance) for tomosynthesis plus 2D compared to 2D alone
·        Signficant gain in diagnostic accuracy for non-calcification cases (masses and distortion) for tomosynthesis plus 2D compared to 2D alone
·        Significant gain in  diagnostic accuracy for calcifications for tomosynthesis plus 2D compared to 2D alone
·        The combination of FFDM plus tomosynthesis offers the potential for improved cancer detection and reduced recall rates in women with dense breasts

4.            Digital Breast Tomosynthesis vs Supplemental Diagnostic Mammography Images for the Evaluation of Noncalcified Breast Lesions
                Zuley M, Sumkin J, Ganott M, Bandos A, Kelly A, Lu A, Catullo V, Chough D, Gur D, Perrin R; RSNA 2011, MSVB31-06 Breast Series: Emerging Technologies in Breast Imaging

                Overview:
Retrospective review of diagnostic 2D and tomosynthesis images of 217 accrued lesions to compare diagnostic performance of tomosynthesis to additional diagnostic mammographic views

Key Results and Conclusions:
·        Tomosynthesis has comparable sensitivity and specificity to standard diagnostic additional mammographic views in non-calcified breast lesions
·        Tomosynthesis may be able to replace additional diagnostic mammographic images in the evaluation of patients suspected of having a non-calcified lesion

5.            A Two-fold Dose Reduction in Breast Screening with Tomosynthesis (DBT) through the Use of Reconstructed 2D Images from the DBT Dataset
                Gur D, Zuley M, Lu A, Anello M, Rathfon G, Abrams G, Hakim C, Wallace L, Chough D, Ganott M, Perrin R, Sumkin J
                RSNA 2011, MSVB31-09 Breast Series: Emerging Technologies in Breast Imaging

                Overview:
Retrospective reader study of 114 cases comparing the performance of synthetically reconstructed 2D with tomosynthesis to FFDM with tomosynthesis

                Key Results and Conclusions:
·        Moderately higher sensitivity with same sensitivity seen using true FFDM images compared to synthetically reconstructed 2D images, both combined with tomosynthesis
·        Minor improvement in quality of synthesized 2D images could lead to acceptable diagnostic quality (Note: an older reconstruction algorithm was used for these images; current version is expected to show greatly improved performance)

Hologic’s Selenia Awarded

Hologic’s Selenia Awarded

By Zacks Investment Research on  | More Posts By  | Zacks.com
In a major achievement, Hologic (NASDAQ:HOLX) won a gold Medical Design Excellence Award (MDEA) award for its Selenia Dimensions 2D/3D mammography system. MDEA, organized by the leading business-to-business media company UBM Canon, is a premier awards program that recognizes the achievements of medical devices manufacturers.
In the past, Hologic has received the gold MDEA award thrice – the Sentinelle Vanguard breast imaging and interventional coil in 2010, ThinPrep imaging system in 2004 and MammoSite radiation therapy system in 2003.
In February 2011, Hologic received approval from the US Food and Drug Administration (FDA) for its Selenia Dimensions three-dimensional (3D) digital mammography tomosynthesis system. Selenia has been developed on the Dimensions platform utilizing tomosynthesis technology to produce both 3D and the conventional two dimensional (2D) full field digital mammography (FFDM) images. The images can be used to screen and diagnose breast cancer. The product is already approved for providing 2D images. The Dimensions platform had received CE mark approval in Europe in fiscal 2008 and Canadian registration in March 2009, both for 2D and 3D modes of imaging.
Although a patient’s exposure to radiation would increase, the accuracy of detection of the disease is better with a combination of both 2-D and 3-D images. Following its approval, the product was immediately launched in the US. There are 12,000 mammography systems running in US consisting of 9,000 digital and 3,000 analog. Since approval, the company has upgraded a number of domestic systems and is pleased with the early uptake so far although adoption of the product will come about gradually. Consequently, a rapid ramp up in system sales is not expected this year.
Approval of the product will be of great help to the huge patient population. It is estimated that more than 40,000 women in America died from breast cancer in 2009. The stage at which the cancer is detected is significant as it is the right time to take medical recourse to increase woman’s survival.
With a wide range of products, Hologic has become an industry giant in the field of women’s health products. Although the Diagnostics segment has been suffering for the past few quarters due to lower doctor visits owing to economic uncertainty, the situation is gradually stabilizing. Moreover, the company is also undertaking several steps, including acquisitions, international expansion and product development to bolster its top line.