1. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CHAPTER 22 Breast Cancer Diagnostic Technologies: Today and Tomorrow

2. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins “FIRST, DO NO HARM…” FDA APPROVAL PROCESS Approval simply means “safe for intended use” Before use, must pass FDA approval process Approval overseen by Center for Devices and Radiological Health of the FDA Some may also require review by FDA’s Center for Drug Evaluation and Research due to injectable radionuclides

3. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins FDA APPROVAL PROCESS Before undergoing approval, classified into category: –Class I: General Controls –Class II: Performance Standards and Special Controls –Class III: Premarket Approval (PMA) Two main pathways to FDA approval: PMA and 510(k) Clinical studies may be performed if granted Investigational Device Exemption (IDE) –IRB oversight may be required

4. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins RATING PERFORMANCE SENSITIVITY & SPECIFICITY OF NEW TECHNOLOGIES Sensitivity: Measures proportion of actual positives that are correctly identified, or probability of a positive test among patients with the disease –How often technology successfully finds lesions Specificity: Measures proportion of negatives that are correctly identified, or probability of a negative test among patients without disease –How accurately it can determine what the lesion is

5. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins AVAILABLE AND ACCEPTED “STANDARD OF CARE” DIAGNOSTIC TECHNOLOGIES Mammography – film/screen and FFDM Ultrasound Core biopsy Computer-aided detection Magnetic resonance imaging of the breast

6. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins MAMMOGRAPHY – FILM/SCREEN AND FFDM “Gold standard” of breast imaging Most accurate and cost-effective method of screening Sensitivity of 75% to 90% Specificity of 90% to 95% Is not perfect – does not find all cancers

7. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ULTRASOUND Most recognized adjunctive imaging technology Very dense breast tissue Not recommended as screening tool due to inability to detect microcalcifications –Insurance providers will not reimburse for screening ultrasound Operator-skill dependent Difficulty providing reproducible results

8. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ULTRASOUND

9. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CORE BIOPSY Can be performed under x-ray, ultrasound, MRI, or clinical guidance Obtain small specimen with biopsy needle Can be performed in physician’s office with local anesthesia Receive results within 24 to 48 hours Cost saver versus open surgical biopsy

10. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins COMPUTER-AIDED DETECTION (CAD) Detection and classification of microcalcifications and masses CAD goals –Improve mammographic sensitivity by increasing detection of potentially significant lesions –Improve specificity by reducing false-positive interpretations –Reduce number of biopsies of benign lesions

11. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins COMPUTER-AIDED DETECTION (CAD) Computer flags “areas of concern” for radiologist to investigate further Similar to spell-check program Radiologist must decide to accept or reject the computer’s finding

12. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins COMPUTER-AIDED DETECTION (CAD)

13. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins MAGNETIC RESONANCE IMAGING OF THE BREAST Accepted method of breast imaging for wide range of purposes –Determining extent of disease in newly diagnosed –Following response to chemotherapy –Follow-up to determine cancer recurrence –Evaluate surgical scars –Search for occult primary cancer –Silicone implant rupture –Screening high-risk patients

14. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins IMAGING TECHNOLOGIES WITH LIMITED APPLICATIONS Scintimammography, also known as molecular breast imaging or breast-specific gamma imaging Positron emission tomography (PET), positron emission mammography (PEM) Optical imaging and optical spectroscopy Thermography Electrical potential measurements Electrical impedance imaging Electronic palpation

15. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins PEM

16. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins SCINTIMAMMOGRAPHY

17. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins PET

18. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ART SOFTSCAN SYSTEM

19. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ON THE HORIZON: PROMISING NEW IMAGING TECHNOLOGIES Breast tomosynthesis Cone beam breast CT New ultrasound methods –Compound –Doppler –3D –Full breast –Elastography

20. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins TOMOSYNTHESIS

21. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins TOMOSYNTHESIS

22. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins TOMOSYNTHESIS

23. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CONE BEAM CT (CBCT)

24. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CBCT

25. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CBCT

26. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CBCT

27. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CBCT

28. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CBCT

29. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins AUTOMATED BREAST ULTRASOUND (ABUS)

30. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ABUS

31. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ABUS

32. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ABUS

33. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins BIOLOGICAL CHARACTERIZATION TECHNOLOGIES Genetic testing (BRCA1, BRCA2) Nipple aspiration breast lavage Cancer markers in serum or blood (salivary markers)

34. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins DUCTAL LAVAGE

35. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins DUCTAL LAVAGE

36. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins DUCTAL LAVAGE