Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CHAPTER 22 Breast Cancer Diagnostic Technologies: Today and Tomorrow
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
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
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
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
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
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
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ULTRASOUND
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
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
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
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins COMPUTER-AIDED DETECTION (CAD)
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
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
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins PEM
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins SCINTIMAMMOGRAPHY
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins PET
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ART SOFTSCAN SYSTEM
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
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins TOMOSYNTHESIS
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins TOMOSYNTHESIS
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins TOMOSYNTHESIS
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CONE BEAM CT (CBCT)
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CBCT
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CBCT
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CBCT
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CBCT
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins CBCT
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins AUTOMATED BREAST ULTRASOUND (ABUS)
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ABUS
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ABUS
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins ABUS
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)
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins DUCTAL LAVAGE
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins DUCTAL LAVAGE
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins DUCTAL LAVAGE