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One in eight women will develop breast cancer

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    One in eight women will develop breast cancer One in eight women will develop breast cancer Document Transcript

    • Breast Specific Gamma Imaging (BSGI) :A Novel Approach to Breast One in eight women will 211,240 cases of IBC and 58,490 Cancer Detection develop breast cancer DCIS diagnosed this year Rachel F. Brem, MD Director, Breast Imaging and Intervention Professor and Vice Chair Department of Radiology The George Washington University Washington, DC 96 Breast Cancer Breast Cancer • 29% cancers in women • 40,410 deaths annually • 18% of cancer deaths in women 96% of breast cancers detected early can be treated successfully Five Year Survival for Breast Breast Cancer- Prevention Breast Cancer- Prevention Cancer • Drug therapy for prevention • Only true, currently available approach for Early Stage 95% prevention • Must detect when localized and curable – All others are risk reduction Late Stage 20% 1
    • Mammograms lower mortality Decrease in Mortality from Breast rate by up to 44% CA • From 1975-1990 the death rate from breast cancer increased by 0.4% annually The Most Widely Utilized • Between 1990 and 2002 the rate decreased Screening for Breast Cancer is by 2.3% annually Mammography • Percentage of decline was greater among younger women • Breast – 1990-2002 decreased by 3.3% in women < 50 cancer – 2.0% in women > 50 screening American Cancer Society Breast Cancer Fact and Figures 2005-2006 Decrease in Mortality from Breast Problems with Mammography Mammography CA • Meta-analysis on impact of improved screening and improved treatment • Do Not Diagnose Enough Breast Cancers (Chemotx) on decrease in mortality • Decreased sensitivity (65%) in: – mammography is an IMPERFECT examination • 10-15% of breast cancers are not mammographically – dense breasts –60% due to improved screening visible – post surgical breast –40% due to improved treatment – implants • 35% of breast cancer is NOT MAMMOGRAPHICALLY VISIBLE Breast Cancer Problems with Mammography Mammography • Do Not Diagnose Enough Breast Cancers How can we improve breast cancer detection – mammography is an IMPERFECT examination • only 20-30% of suspicious lesions prove • 10-15% of breast cancers are not mammographically visible to be malignant at biopsy 2
    • Breast Cancer Breast Imaging • Mammography Scintimammography • How can we improve differentiating – anatomic approach to imaging the breast benign from malignant disease and (General Purpose Gamma Camera) – limitations thereby decrease the need for breast biopsy for benign lesions • Ultrasound – most common adjunct imaging modality – anatomic approach as well Clinical RESULTS Objectives of the Two Scintimammography Breast Scintimammography Scintimammography Breast Imaging Imaging Trial: Multicenter Clinical Trials 100% • nuclear medicine examination for the diagnosis of 80% breast cancer •Determine the accuracy of Tc99m Sestamibi Reader 1 • physiological vs anatomic examination scintigraphic images in identifying malignant 60% – Miraluma (Bristol Myers Squibb) breast lesions Reader 2 – Uses traditional, multi-purpose gamma camera 40% • Patients with palpable abnormalities Reader 3 – 99m technetium sestamibi – FDA approved, 1997 20% – identical to Cardiolite 0% – longstanding safety record • Patients with non-palpable, mammographic SENSITIVITY SPECIFICITY PPV NPV ACCURACY abnormalities Miraluma™ Breast Imaging Trial: Clinical Dense vs Fatty Breast Tissue Non-Palpable Miraluma™ Breast Imaging Trial: Scintimammography Clinical Imaging Trial Abnormality Non-Palpable Abnormality RESULTS Breast Imaging 100% SENSITIVITY 100% 100% 80% 80% 80% Fatty Reader 1 Reader 1 60% 60% 60% Dense Reader 2 Reader 2 40% 40% 40% Reader 3 Reader 3 20% 20% 20% 0% 0% 0% READER 1 READER 2 READER 3 READER 1 READER 2 READER 3 SENSITIVITY SPECIFICITY PPV NPV ACCURACY SENSITIVITY SPECIFICITY <1 cm ≥1 cm 3
    • Scintimammography Conclusions-Advantages Conclusions-Disadvantages •Scintimammography is indicated for planar imaging as a • Scintimammography had • Scintimammography had second line diagnostic tool after mammography to assist in – High sensitivity – Significant limitations in sensitivity in non- the evaluation of breast lesions in patients with an – Specificity significantly higher than palpable and less than 1 cm lesions (small abnormal mammogram or a palpable breast mass. mammography lesions) – No significant difference in detection in – Inability to image in positions comparable to fatty vs dense breasts mammography due to limitations of available equipment High Resolution Scintimammography Scintimammography Scintimammography Camera • must improve resolution to image • pixelated crystal small breast cancer • proof of principle • position sensitive photomultiplier tube – mean cancer size 2.2 cm • largest issue is resolution • portable • optimize survival by detecting cancers less • versatility of standard gamma camera • smaller detector size than 1 cm limited • smaller lesion to detector distance – smallest size imaged 7 mm • cranio - caudal view • 2 - 3 mm edge effect on 3 sides • majority of lesions palpable – must reliably detect non-palpable lesions for optimal survival • 4
    • Clinical Trial Comparison of BSGI and GPGC Dilon Clinical Trial Results: Sensitivity • Objectives • Compare scintimammographic GammaCamera HRBSGC findings using a traditional gamma • Improved Sensitivity from 64.3% to 78.6% All cancers 64% (18/28) 79% (22/28) camera and the High Resolution – Improved sensitivity in subcentimeter Cancers < 10 mm 47% (7/15) 67% (10/15) Breast Specific Gamma Camera lesions from 46.7% to 66.6% Non-palpable cancers 56% (10/18) 72% (13/18) (HRBSGC) in sequential patients • Prototype detector Palpable cancers 80% (8/10) 90% (9/10) referred for scintimammography for clinical indications Cancers > 10 mm 85% (11/13) 92% (12/13) • All patients had biopsy proven findings Brem RF, Schoonjans JM, Kieper DA, Majewski S. High-resolution scintimammography: A pilot study. J Nucl Med 2002; 43:909-915. Brem RF, Schoonjans JM, Kieper DA, Majewski S. et al High-resolution scintimammography: A pilot study. J Nucl Med 2002; 43:909-915. HRBSGC Clinical Trial Clinical Trial Clinical Trial Conclusions: • Conclusions: • Overall sensitivity of breast cancer • Overcome intrinsic limitation of nuclear detection improved medicine imaging of the breast in clinical Results: practice • Improvement greatest in sub-centimeter • Lesions: 41/58 (71%) NOT palpable • Sub-centimeter resolution cancers • Size: 3-60 mm (median 11 mm) • Imaging in mammographic position • HRBSG camera improved detection of < 1cm cancers to a level comparable to all • Optimize breast imaging cancers detected with the conventional • Integration of Nuclear Medicine Imaging gamma camera of the breast in clinical practice What about screening high-risk High Resolution Nuclear women? Imaging of the Breast • Clinical Trial at GW Medical Center • Improve sensitivity of mammography in women at increased risk – High risk women (equal to STARR trial) – Normal mammogram and clinical examination – initially designed for dense breasts – Annual “screening” with high resolution nuclear – at initiation of trial included all women at medicine camera increased risk • Abnormalities will be evaluated with ultrasound • Adjunct to improve diagnosis of breast • Can be localized intra-operatively with pre-operative cancer in women at increased risk injection Brem RF, Rapelyea JA, Zisman G et al. Occult Breast Cancer: Scintimammography with High-Resolution Breast-specific Gamma Camera in Women at High Risk for Breast Cancer Radiology,2005,237 5
    • Materials and Methods Results Materials and Methods • 25-30 mCi Technitium sestamibi injected in 94 Total Patients • Criteria for inclusion the antecubital vein • 78 (83%) Negative BSGI – normal mammogram (BI-RADS 1 or 2) • Imaging immediately following injection • 16 (17%) Positive BSGI for 6-8 minutes per image – normal physical examination • Patient sitting Brem RF, Rapelyea JA, Zisman G et al. Brem, Rapelyea, Zisman et al. Occult Breast Cancer: Occult Breast Cancer: Scintimammography with High-Resolution Breast-specific Scintimammography with High-Resolution Breast-specific Gamma Camera in Women at High Risk for Breast Cancer Radiology,2005,237 Gamma Camera in Women at High Risk for Breast Cancer Radiology,2005,237 Results Results Results • True Negatives • False Positives • Histopathology of biopsy proven false- – All 78 patients – 14 (88%) of the 16 patients with positive positives – Normal mammogram, physical exam, and BSGI determined to be benign scintimammogram at year 1 and year 2 imaging –7 with fibrocystic change • 5 patients confirmed by negative ultrasound • False Negatives • 1 with concomitant sclerosing adenosis • 9 patients confirmed by benign biopsy – Normal scintimammogram with abnormal – All were followed for 1 year subsequent to –1 fibroadenoma mammogram, ultrasound, or physical exam, who BSGI, mammogram and PE –1 fat necrosis were found to have cancer at biopsy – 0 false-negatives Fibrocystic Changes Fibroadenoma Fat Necrosis 6
    • Results Results Results • True Positive-Patient # 1 – 6mm lesion identified with ultrasound at • True Positives • 2 Cancers location of focal uptake with scintimammogram – Pathologically measured 8 mm IDC –2 (13%) out of the 16 patients –Detected only with BSGI with positive BSGI –Both had a prior history of breast –Histopathologically infiltrating carcinoma and intraductal carcinoma • One was a local recurrence • One was a contralateral cancer Results Results • True Positive-Patient # 2 BSGI Screening – 8 mm lesion identified with ultrasound at location of focal uptake with scintimammogram – Pathologically measured to be 12 x 10x 10mm • 100% sensitivity • 84.8% specificity • 100% negative predictive value BSGI for Breast Cancer Detection Materials and Methods Material and Methods To determine the sensitivity and • Clinical indications for BSGI specificity of breast specific gamma – palpable finding with no mammo correlate • Retrospective review of 146 imaging (BSGI) for the detection of – evaluation of multicentricity/multi-focality in women (age 32 to 98) undergoing breast cancer, using pathology as the women with biopsy proven cancer BSGI reference standard – Equivocal mammographic finding • breast biopsy was performed – screening women at high risk for breast cancer 7
    • Material and Methods Materials and Methods Results • Studies were classified as: • 146 patients • Patients underwent BSGI with intravenous – positive (focal increased radiotracer uptake) • 167 lesions injection of 30mCi of 99mTc-sestamibi – negative (no focal increased radiotracer uptake – 18 patients underwent biopsy of multiple • Imaged in CC and MLO projections (7-10 or scattered heterogeneous physiologic uptake) lesions: min/image) • 1 patient with four biopsies • compared to biopsy results • 1 patient with three biopsies • 16 patients with two biopsies Cancers Sensitivity of BSGI BSGI Sensitivity of Invasive Cancers • 83 malignant lesions of which • 83 malignant lesions (invasive carcinoma or • 67 invasive cancers DCIS) • BSGI identified cancer in 65 – 67 (80.7%) invasive cancers – 16 (19.3%) DCIS • BSGI identified 80 as malignant Sensitivity of 97.0 % (95% CI 89-99%) Sensitivity = 96.4% (95% CI, 89%-99%) Invasive Cancer BSGI Sensitivity of DCIS BSGI and Cancer Size • Recently completed study Of the cancers whose size was available • 146 invasive cancer • 16 DCIS • the mean size of invasive cancer detected by • BSGI detected 143 • BSGI identified cancer in 15 BSGI was 20 mm (n=56, SD 14 mm, • Sensitivity = 98% median size 15mm) – Only non-visualized cancers were Grade 1 and Sensitivity of 93.8 % (95% CI 69-99%) • Mean size of DCIS detected with BSGI was subcentimeter • 40% of sub-centimeter cancer, Grade 1 were visualized 18 mm (n=9, SD 18 mm, median size • N= 5, need larger study 7mm). – Smallest cancer 2 mm 8
    • Rt CC Rt MLO Sensitivity of BSGI in BSGI and Cancer Size Sub-Centimeter Cancers Both the smallest invasive cancer and the BSGI correctly identified: smallest DCIS detected by BSGI was 1mm 16/18 cancers less than 1cm 46 year old woman: Focal increased radiotracer uptake (arrows) in the Sensitivity = 88.9% upper right breast Pathology demonstrated 0.6 cm *5 invasive cancers and 3 DCIS less than 5 mm infiltrating lobular carcinoma with were detected with BSGI extensive LCIS Lt CC Lt MLO Occult Cancers Detected only with BSGI Positive Predictive Value • BSGI detected occult cancers not • Of 114 patients with a positive BSGI exam visualized with mammogram or ultrasound – 80 were invasive cancer or DCIS in 6 patients (7.2% of cancer patients) •BSGI of 73 year old: Focal radiotracer uptake (circles) • In all 6 the lesion was found with second PPV of 70.2% (95% CI, 60%-78%) in lower outer left breast look ultrasound and underwent ultrasound- • Pathology demonstrated multi- guided biopsy focal DCIS with no focus larger than 4mm. Negative Predictive Value Non-Malignant Lesions Specificity of BSGI • Of 53 patients with a negative BSGI exam 84 nonmalignant lesions for malignancy • 84 lesions – 82 normal or benign • BSGI was negative in 50 – 50 had no evidence of DCIS or invasive cancer, – 2 high risk • Positive in 34 NPV = 94.3% (95% CI, 84%-98%) • 1 ALH • 1 LCIS Specificity of 59.5% (95% CI 48-70%) – Both confirmed at surgery 9
    • False Positive Lesions False Negative Studies BSGI 34 False Positive Lesions 3 cancers • Sensitivity = 97.0% for invasive cancers – Documented by biopsy • 1 DCIS, 2 IDC (3-10 mm) • Sensitivity 93.8% for the detection of DCIS – 1 DCIS: High grade, measured 10 mm and was detected – Most common pathology is Fibrocystic Change mammographically with retroareolar microcalcs • This sensitivity is comparable to that reported – 8 patients with FP had a biopsy in the preceding – 2 IDC in MRI for invasive cancers (90.9%) and 2 months in area of increased radiotracer uptake • 7 mm: Axillary tail (? positioning) DCIS (93%) • ? Inflammatory change • 3 mm: Incidental cancer found at prophylactic mastectomy in a patient with a contra-lateral breast – Although larger study populations are needed, cancer. these findings support the potential of BSGI – not identified with mammography, ultrasound or clinical examination Conclusions Conclusions: BSGI vs MRI • 7.2% of patients with cancer had occult foci • Our study supports the use of BSGI as MRI detected with BSGI not detected with other would be used in clinical practice with equal imaging modalities sensitivity and higher specificity • Given the high sensitivity of BSGI, it can be • Greater ease for the patient considered as a pre-surgical exam in patients • 4-8 images as compared to hundreds of with biopsy proven cancer to look for images additional foci as well as contralateral breast • Easily integrated into a breast imaging site cancer. DCIS: DCIS: Sensitivity Mammo, MRI, BSGI and DCIS • 20 women • Mammography 82% • 22 biopsy proven DCIS • MRI 88% –Size: 2-23 mm (mean 9.9mm) • BSGI 91% Brem RF, Fishman MC, Rapelyea JA et al, Academic Radiology 2007; 14 :945-950 10
    • DCIS and BSGI DCIS and MRI BSGI vs MRI • Smallest DCIS detected with BSGI: 2 mm – 7 patients with 8 biopsy proven DCIS • 2 occult DCIS lesions detected only with – 7 areas of abnormal enhancement (sensitivity 88%) • 23 patients with 33 indeterminate lesions BSGI • occult contralateral DCIS in one patient with bilateral – Indeterminate breast finding requiring • 2 false negative DCIS lesions with BSGI disease MRI and BSGI as part of their work up – Both detected with microcalcifications – Detected initially with BSGI mammographically • one false negative MRI examination, which at surgical – 9 pathologically proven cancers in 8 excision demonstrated a 4 mm DCIS patients • false negative MRI was positive with BSGI. Brem RF, Petrovitch I, Rapelyea JA. The Breast Journal, 2007 ;13 465-469. BSGI vs MRI BSGI and MRI BSGI vs MRI • 4 ductal carcinoma in situ, 7 false positives BSGI lesions: • 3 infiltrating ductal carcinomas – 6 FC • Sensitivity: Equal – 1 sub-clinical abscess following TRAM reconstruction • 1 invasive lobular carcinoma • 1 infiltrating carcinoma with duct and • Specificity: 27% MRI 18 false positive MRI studies lesions – 11 FCD lobular features 75% BSGI – 4 lobular neoplasia – 1 fibrosis with foreign body giant cell reaction – 1 abscess – 1 no lesion visualized at biopsy with long term follow up Infiltrating Lobular Carcinoma Infiltrating Lobular Carcinoma • 4 Institutions Right MLO Right CC •Difficult to identify mammographically – 2 academic, 2 private practice •Difficult to palpate clinically • 26 women (ages 46 to 82 (mean age 62.8) with 28 biopsy proven pure ILC •Lower sensitivity with MRI than other • mean size of 22.3mm (2mm-90mm) invasive cancers( 60% vs 90%) Right Lateral 11
    • Infiltrating Lobular Carcinoma Infiltrating Lobular Carcinoma Infiltrating Lobular Carcinoma • Mammograms: Negative in 6/28 (21%) • Abnormal mammographic findings, 22/28 • Ultrasound (n=25) • MRI (n=12) – 13 asymmetric densities • 17/25 focal hypoechoic areas • 10/12 lesions demonstrating enhancement – 4 architectural distortions • Sensitivity = 68% • Sensitivity of MRI was 83%. – 5 spiculated masses • Mammography had a sensitivity of 79%. Known RT ILC Invasive Lobular Carcinoma No other known abnl Rt. MLO Infiltrating Lobular Carcinoma Right CC Right CC Right MLO • BSGI : Focal tracer uptake 26/28 cases • Sensitivity = 93%. Left MLO Left CC Left CC Left MLO BSGI and Assessment Post Breast Specific Gamma Imaging BSGI Lumpectomy • Clinical Uses: • Assessment of positive margins following – All newly diagnosed breast cancer lumpectomy • Surgical planning – Surgical planning • Occult foci of cancer – Extent of residual disease – High Risk Screening • Even with normal mammo and/or PE – Equivocal mammographic finding – Positive axillary adenopathy with no known primary 12
    • BSGI and Direct Silicone Injection State of the Art • Commercially available • FDA approved • Extremely difficult mammographic interpretation • Reimbursed • Adjunct imaging modality needed • Numerous units are currently installed and more on order • It is HERE AND NOW!!!!! Localization of Area of Focal Comparison to PET BSGI:Conclusions Uptake • Radiotracer cost • Must localize or biopsy for integration into – Have dose delivered every morning clinical practice – Available and on hand – Optimally must be able to biopsy minimally • Molecular Imaging of the Breast • Availability of radiotracer and dose invasively • Multiple Clinical Indications • Minimal modifications to allow radiotracer in • Technology for minimally invasive biopsy • Important Adjunct Imaging Modality for the breast center (dose comparable to sentinel node) exists improved diagnosis of breast cancer • Cost – translation of mammographically obtained • Easily and effectively integrated into Breast • Reimbursement stereotactic biopsy Center BGSI: Ongoing Studies Fusion Imaging • Lymph Node Assessment – Perhaps decrease number of surgical procedures • Improved differentiation of benign from malignant – Background to lesion ratio • Response to Neo-adjuvant chemotherapy • Fusion imaging Courtesy of Jefferson Lab, Hampton University and Riverside Regional Medical Center 13