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CHAPTER 22

CHAPTER 22. Breast Cancer Diagnostic Technologies: Today and Tomorrow. “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

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CHAPTER 22

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  1. CHAPTER 22 Breast Cancer Diagnostic Technologies: Today and Tomorrow

  2. “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. 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. RATING PERFORMANCESENSITIVITY & 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. 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. 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. 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. ULTRASOUND

  9. 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. 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. 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. COMPUTER-AIDED DETECTION (CAD)

  13. 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. 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. PEM

  16. SCINTIMAMMOGRAPHY

  17. PET

  18. ART SOFTSCAN SYSTEM

  19. ON THE HORIZON: PROMISING NEW IMAGING TECHNOLOGIES • Breast tomosynthesis • Cone beam breast CT • New ultrasound methods • Compound • Doppler • 3D • Full breast • Elastography

  20. TOMOSYNTHESIS

  21. TOMOSYNTHESIS

  22. TOMOSYNTHESIS

  23. CONE BEAM CT (CBCT)

  24. CBCT

  25. CBCT

  26. CBCT

  27. CBCT

  28. CBCT

  29. AUTOMATED BREAST ULTRASOUND (ABUS)

  30. ABUS

  31. ABUS

  32. ABUS

  33. BIOLOGICAL CHARACTERIZATION TECHNOLOGIES • Genetic testing (BRCA1, BRCA2) • Nipple aspiration breast lavage • Cancer markers in serum or blood (salivary markers)

  34. DUCTAL LAVAGE

  35. DUCTAL LAVAGE

  36. DUCTAL LAVAGE

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