Fremtidens rolle for tomosyntese

Transcription

1 Dansk Radiologisk Selskab 9.årsmøde Odense 3.januar, 214 Fremtidens rolle for tomosyntese Professor dr. med. Per Skaane Oslo University Hospital Ullevaal Breast Imaging Center Oslo / Norway PERSKA@ous-hf.no 3 min

2 Dansk Radiologisk Selskab 9.årsmøde Odense 3.januar, 214 Objectives: Fremtidens rolle for tomosynthesis (DBT) Potential role of tomosynthesis in clinical breast imaging Potential role of tomosynthesis in screening Do we need 2D? Tomo in one or both (CC + MLO) views? The role of synthetic 2D images The Oslo Tomosynthesis Screening Trial (OTST) Overview of results from DBT in breast cancer screening Summary Disclosure: Oslo Tomosynthesis Screening Trial Equipment and support for additional reading provided by Hologic, Inc.

3 Tomosynthesis ( 3D Mammography ) Screening unit Oslo ( Galleriet ) Oslo Tomosynthesis Screening Trial : Two Dimensions ( Hologic)

4 Indication for tomosynthesis: Dense breast parenchyma Screen 2D R MLO Screen TOMO R MLO

5 Tomosynthesis: Potential for increased sensitivity R MLO: 2D (FFDM) R MLO: 3D (Tomosynthesis)

6 Potential role of DBT in the clinical setting Microcalcifications: DBT equal/comparable to FFDM for detection/clarity - Spangler ML: AJR 211;196:32 - Kopans D: Breast J 211;17:638 Tumor size assessment: DBT superior to FFDM - Fornvik B: Acta Radiol 21;51:24 - Mun HS: Clin Radiol 213;68:1254 Specificity increased when used adjunctively with FFDM: - Poplack SP: AJR 27;189:616 - Gur D: AJR 29;193:586 Mass characterization: Superior cancer visibility and conspicuity - Andersson I: Eur Radiol 28;18:2817 Replacement of supplemental diagnostic views for non-calcified lesions - Brandt KR: AJR 213;2:291 - Zuley ML: Radiology 213;266:89

7 Images to be included in TOMO screening: One view TOMO only (mlo)? One view 2D (cc) + one view TOMO (mlo)? Two view 2D (mlo + cc) + one view TOMO (mlo)? Two view TOMO (cc + mlo)? Two view 2D (mlo + cc) + two view TOMO (mlo + cc)? Oslo Tomosynthesis Screening Trial: Two view 2D (mlo + cc) + two view TOMO (mlo + cc )

8 Do you see the distortion? R MLO: FFDM (2D) R MLO: Tomo (3D)

9 Tomosynthesis (DBT) in breast cancer screening Why do we need 2D (FFDM) in addition to tomosynthesis: Needs 2D for comparison of priors vs. current exams Needs 2D for comparison right vs left breast Current 2D exam might be requested by other institutions Studies so far have shown that the combination of 2D + DBT has higher sensitivity (cancer detection) and specificity (lower recall rate) Two view 2D (CC+MLO) plus two view DBT (CC+MLO) means approximately a «doubling» of the radiation dose! However: Synthetic 2D views may substitute for FFDM images when combined with tomosynthesis, reducing substantially the radiation dose (approximately 45%)!!

10 Synthetic 2D: Synthetic 2D image 2D C-View Tomo L CC L CC L CC

11 Synthetic 2D image Left CC: 2D Left CC: C-View Left CC: Tomo

12 ClinicalTrials.gov Tomosynthesis in the Oslo Breast Cancer Screening Program (DBT) ClinicalTrials.gov Identifier: NCT Estimated Enrollment: 25, Study Start Date: November 21 Estimated Primary Completion Date: December 212 (Final data collection date for primary outcome measure) Oslo Tomosynthesis Screening Trial: Part of the Norwegian Breast Cancer Screening Program Age group 5-69 years Two-view (CC and MLO) mammography Independent double reading with consensus (arbitration) 5-point rating scale (1=normal/benign; 2-5=positive score) On-line reporting directly into the database of the Norwegian Cancer Registry

13 Oslo Tomosynthesis Screening Trial (OTST) a) Women 5-69 y. attending the screening unit invited to participate in the OTST, if: * Availability of radiographers * Availability of equipment Excluded: Women with implants Women NOT included: FFDM (2D) only Independent double reading Women included: FFDM (2D) + TOMO (3D) Independent double reading

14 OTST: Cancer right breast R MLO: 2D R MLO: Tomo (3D)

15 Tomosynthesis-guided biopsy Pre-fire Post-fire Hologic Proprietary - For Educational Purposes Only - rev1 - PRE-379

16 OTST: Batch reading for combo mode (2D FFDM + DBT) Hanging protocol step 1-8 a) Prior CC Prior MLO Current CC dext Current CC sin Current CC Current MLO 1 2 Current MLO dxt Current MLO sin Current FFDM CC dext Current TOMO CC dext 3 4

17 OTST: Batch reading for combo mode (2D FFDM + DBT) Hanging protocol step 1-8 b) Current FFDM MLO dext Current TOMO MLO dext Current FFDM CC sin Current TOMO CC sin 5 6 Current FFDM MLO sin Current TOMO CC sin Prior CC Prior MLO Current CC Current MLO 7 8

18 Oslo Tomosynthesis Screening Trial (OTST): First year results * Women 2D + (2D+3D): n = 12, 631 Malignancy: n = 13 Malignancy rate: 1.3% Excl. 1 women with malignancy: - 2 palp. cancer (clin recall) - 3 Interval cancers ( IC ) - 5 Lymphomas/metastases Arm A (2D): n =12,621 Cancers: n = 77 Cancer detection rate:.61% Arm C (2D + 3D): n = 12,621 Cancers: n = 11 Cancer detection rate:.8% Relative increase in cancer detection ( 2D+TOMO ) vs. ( 2D ): 31% Relative increase in cancer detection: 31% (p<.5) * Skaane P et al.: Radiology 213; 267: 47-56

19 Mammography screening: Comparison of conv. 2D vs. 2D + tomo ( combo )* Parameter Detected with 2D only Detected with combo only Detected with 2D and combo Total with 2D Total with combo Difference combo vs 2D No. cancer Inv. Cancer IDC IDC+DCIS ILC Others Radiol. finding Circ.mass Spicul.mass Distortion Asymm.dens Mc Density+mc DCIS Low grade High grade * Skaane P et al.: Radiology 213; 267: 47-56

20 Tomosynthesis in breast cancer screening: Studies comparing FFDM and Digital Breast Tomosynthesis DBT (August 213) Study Population ( n ) Study design Examination mode Reading mode Trento/Verona (STORM)1 7,292 Prospective; paired 2D: 2-view 3D: 2-view Double; Sequential Oslo (OTST) 2 12,631 Prospective; paired 2D: 2-view 3D: 2-view Double; Independent TOPS Compr. Breast 3 Center, Houston, TX 2D: 13,856 3D: 9,499 Retrospective; non-paired 2D: 2-view 3D: 2-view Single; Independent Yale University 4 (New Haven, CT) 2D: 7,58 3D: 6,1 Retrospective; non-paired 2D: 2-view 3D: 2-view Single; Independent Malmø (MBTST) 5 5,7 Prospective; paired 2D: 2-view 3D: 1-view Double; Sequential 1) Ciatto S et al.: Lancet Oncol, 213 (Screening with Tomo OR standard Mammo (STORM)) 2) Skaane P et al.: Eur Radiol, 213 (Oslo Tomosynthesis Screening Trial OTST) 3) Rose SL et al.: AJR, 213 (Implementation of breast tomo in a routine screening practice) 4) Haas BM et al.: Radiology, 213 (Comparison of tomo plus 2D and 2D alone for screening) 5) Zackrisson S: ECR Vienna, 213 (Interim analysis; Malmø Breast Tomosynthesis Screening Trial)

21 Tomosynthesis in breast cancer screening: Studies comparing FFDM and Digital Breast Tomosynthesis DBT (August 213) Study Population ( n ) Cancer ( n ) 2D 2D+3D Cancer ( n / 1, ) 2D 2D+3D Cancer: Rel. increase ( % ) Trento/Verona (STORM)1 7, % Oslo (OTST) 2 12, % TOPS Compr. Breast 3 Center, Houston, TX Yale University 4 (New Haven, CT) 2D: 13,856 3D: 9,499 2D: 7,58 3D: 6, % 9.5 % Malmø (MBTST) 5 5, % 1) Ciatto S et al.: Lancet Oncol, 213 (Screening with Tomo OR standard Mammo (STORM)) 2) Skaane P et al.: Eur Radiol, 213 (Oslo Tomosynthesis Screening Trial OTST) 3) Rose SL et al.: AJR, 213 (Implementation of breast tomo in a routine screening practice) 4) Haas BM et al.: Radiology, 213 (Comparison of tomo plus 2D and 2D alone for screening) 5) Zackrisson S: ECR Vienna, 213 (Interim analysis; Malmø Breast Tomosynthesis Screening Trial)

22 US: State mandatory Breast Density notification Withholding medical information from patients without their knowledge or consent is ethically unacceptable. Am. Med. Assoc. Ethical Guidelines (Opinion 8.82 The addition of breast MRI or ultrasound to mammography increases the detection of small node-negative cancers beyond that achieved with mammography alone. Berg, 28 PINK: Enacted Law RED: Introduced Bill BLUE: Working on Bill WHITE: No Action BLACK * : Insurance Coverage Law

23 Potential techniques as adjunct to mammography for personalized screening in women with dense breasts: 1) Ultrasonography: ABUS performed by radiographers Availability: Costs: Favour Disfavour Automated Breast Volume Scanning 2) Breast MRI: Highest sensitivity Availability: Costs: Disfavour Disfavour Short first-pass MRI of the breast. Normal findings. MIP acquired in 4:35 min 3) Tomosynthesis: Not another modality - just «a better mammogram»! Availability: Favour Costs: Favour

24 Thank you very much for your attention! The Mammography Screening Team in Oslo