ESOBI 2017 Poster DRAFT -...
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P20 Multi-centre Symptomatic Assessment of a Radio-wave Breast Imaging System I. Lyburn 2 , R. Geach 2 , L. Hobson 2 , L. Jones 1 , H. Massey 1 , N. Ridley 3 , M. Schoenleber-Lewis 4 , S. Taylor 3 , P. Bannister 4 , M. Shere 1 1 - Bristol Breast Care Centre, North Bristol NHS Trust; 2 - Thirlestaine Breast Centre, Cheltenham; 3 - Great Western Hospitals NHS Foundation Trust, Swindon; 4 - Micrima Limited, Bristol ([email protected]) Purpose Radio-wave imaging shows great promise as a non-compressing, whole-breast modality that does not employ ionising radiation. Previous work has demonstrated that the underlying dielectric contrast mechanism enables a high sensitivity for lesion detection (in particular, cancer) in dense tissue. This work is the first report on all cases collected from a post-market, multi-centre symptomatic study of the MARIA™ System (Micrima Limited, Bristol) showing high sensitivity in dense (and in particular in extremely dense) tissue in the UK. Conclusions and Summary Statement MARIA™ continues to show great promise, initially as a non-compressing, whole-breast adjunct to established symptomatic modalities with clear benefits in cases of dense tissue. The results from this multi-centre trial are consistent with an overall Sn of 73% (66/90) obtained in a pre-market symptomatic assessment. This is the first report on all cases from a multi-centre symptomatic study showing high sensitivity in extremely dense tissue. Women with ‘dense’ breasts have a higher percentage of fibrous tissue plus glandular tissue, and less fatty tissue. In contrast, women with ‘lucent’ tissue have a higher percentage of fatty tissue and less fibrous/glandular tissue. For mammographic analysis, dense breast composition may obscure masses and lower the sensitivity and despite improvements over mammography, tomosynthesis still misses a substantial number of invasive cancers in women with dense breasts [4]. Methods Females attending symptomatic breast clinics at one of 3 symptomatic clinics (Southmead, Bristol; Thirlestaine, Cheltenham; Great Western Hospital, Swindon), were identified by clinicians as having a palpable lump. Following informed consent, eligible patients meeting inclusion criteria were scanned in the prone position with MARIA™, a non-ionising, multi- static radar system (REC 15/YH/0084; NCT02493595). Patients had ultrasound (US) and/or mammography (MMG). Cytology/ histology was conducted as necessary as part of normal clinical procedure to determine final diagnosis. Figure 1: Patient (model) positioned on MARIA™ bed for scanning Results Across all evaluable cases, lesion detection sensitivity (Sn) was 76% (176/232 - age range 16-81). For studies where mammographic density information was available, Sn for heterogeneously dense breasts (BiRAD c) was 87% (66/76) and for very dense (BiRAD d) was 93% (27/29). Sn for cases with no BiRAD density available was 79% (41/52). Considering only diagnoses of cancer, Sn for heterogeneously dense was 78% (18/23) and for very dense, 100% (5/5). References [1] Mammographic Density and the Risk and Detection of Breast Cancer. Boyd et al, NEJM 2007:356:227-36M [2] Radar imaging of breast lesions – a clinical evaluation and comparison. Shere et al, ECR 2016, Vienna [3] MARIA M4: clinical evaluation of a prototype ultrawideband radar scanner for breast cancer detection. Preece et al, JMI, 2016, 3(3) [4] Adjunct Screening With Tomosynthesis or Ultrasound in Women With Mammography-Negative Dense Breasts: Interim Report of a Prospective Comparative Trial. Tagliafico et al, J. Clin. Oncology34, no. 16 (June 2016) 1882-1888. Column1 Cases Sensitivity Score Mean age (years) Age range (years) Cysts (Sensitivity Score) Cancer (Sensitivity Score) Others (Sensitivity Score) All 232 176 (76%) 50 16-81 62/82 (76%) 66/90 (73%) 48/60 (80%) Pre-/ Peri- menopausal 163 121 (74%) 42 16-60 54/72 (75%) 27/39 (69%) 40/52 (77%) Post- menopausal (inc HRT) 68 54 (79%) 68 49-81 8/10 (80%) 38/50 (76%) 8/8 (100%) Lucent tissue (BIRADS a) 14 10 (71%) 67 40-81 N/A 7/10 (70%) 3/4 (75%) Lucent tissue (BIRADS b) 56 37 (66%) 59 34-81 6/11 (55%) 26/37 (70%) 5/8 (63%) Dense tissue (BIRADS c) 78 61 (78%) 50 19-80 32/41 (78%) 18/23 (78%) 11/14 (79%) Dense tissue (BIRADS d) 32 27 (84%) 49 32-81 16/18 (89%) 5/5 (100%) 6/9 (67%) BIRADS Unavailable 52 41 (79%) 39 16-72 8/12 (67%) 10/15 (67%) 23/25 (92%) Figure 2: Sensitivity performance table for MARIA™ by BiRAD density, menopausal status and lesion type (cyst, cancer, other) for 232 single breast studies. Right Left 3 Dimensional View Right (a) (b) (c) (d) (a) (b) (e) (f) (c) (d) 3 Dimensional View Left (f) 3 Dimensional View Right (e) Figure 3: P107 Bilateral, Age 58, BiRAD ‘c’ (a, Right) MMG showing asymmetrical density of indeterminate nature in the UC (b, Left) MMG showing patchy irregular density suspicious of malignancy in the central /medial (c, Right) US showing irregular mass suspicious of malignancy in the UC (d, Left) US showing lump at central breast extending above and below the left nipple (e, Right) MARIA™ is showing cluster of scatters at CC/CI and one lesion at CO (f, Left) MARIA™ is showing two lesions at CO and LO Figure 4: P130 Bilateral, Age 48, BiRAD ‘b’ (b, Left) MMG showing well-defined ovoid low-density opacity consistent with a simple cyst (a, Right) MMG showing area of segmental calcification which is indeterminate (c, Right) and (d, Left) US showing indefinite lesion found in each breast (e, Right) MARIA™ showing 5 clusters of scatter in half of the outer CC area, (f, Left) MARIA™ showing six clusters of scatter in CC/CO/LC and one at upper left CC
Transcript of ESOBI 2017 Poster DRAFT -...
P20Multi-centre Symptomatic Assessment of a Radio-wave Breast Imaging System
I. Lyburn2, R. Geach2, L. Hobson2, L. Jones1, H. Massey1, N. Ridley3 , M. Schoenleber-Lewis4, S. Taylor3, P. Bannister4, M. Shere1
1 - Bristol Breast Care Centre, North Bristol NHS Trust; 2 - Thirlestaine Breast Centre, Cheltenham; 3 - Great Western Hospitals NHS Foundation Trust, Swindon; 4 - Micrima Limited, Bristol ([email protected])
PurposeRadio-wave imaging shows great promise as a non-compressing, whole-breastmodality that does not employ ionising radiation. Previous work has demonstratedthat the underlying dielectric contrast mechanism enables a high sensitivity for lesiondetection (in particular, cancer) in dense tissue. This work is the first report on all casescollected from a post-market, multi-centre symptomatic study of the MARIA™ System(Micrima Limited, Bristol) showing high sensitivity in dense (and in particular inextremely dense) tissue in the UK.
Conclusions and Summary StatementMARIA™ continues to show greatpromise, initially as a non-compressing,whole-breast adjunct to establishedsymptomatic modalities with clearbenefits in cases of dense tissue. Theresults from this multi-centre trial areconsistent with an overall Sn of 73%(66/90) obtained in a pre-marketsymptomatic assessment.
This is the first report on all cases from amulti-centre symptomatic study showinghigh sensitivity in extremely dense tissue.Women with ‘dense’ breasts have ahigher percentage of fibrous tissue plusglandular tissue, and less fatty tissue. Incontrast, women with ‘lucent’ tissue havea higher percentage of fatty tissue andless fibrous/glandular tissue.
For mammographic analysis, dense breastcomposition may obscure masses andlower the sensitivity and despiteimprovements over mammography,tomosynthesis still misses a substantialnumber of invasive cancers in womenwith dense breasts [4].
MethodsFemales attending symptomatic breast clinics at one of 3 symptomatic clinics (Southmead, Bristol; Thirlestaine,Cheltenham; Great Western Hospital, Swindon), were identified by clinicians as having a palpable lump. Following informedconsent, eligible patients meeting inclusion criteria were scanned in the prone position with MARIA™, a non-ionising, multi-static radar system (REC 15/YH/0084; NCT02493595). Patients had ultrasound (US) and/or mammography (MMG).Cytology/ histology was conducted as necessary as part of normal clinical procedure to determine final diagnosis.
Figure 1: Patient (model) positioned on MARIA™ bed for scanning
ResultsAcross all evaluable cases, lesiondetection sensitivity (Sn) was 76%(176/232 - age range 16-81). For studieswhere mammographic densityinformation was available, Sn forheterogeneously dense breasts (BiRAD c)was 87% (66/76) and for very dense(BiRAD d) was 93% (27/29). Sn for caseswith no BiRAD density available was 79%(41/52). Considering only diagnoses ofcancer, Sn for heterogeneously dense was78% (18/23) and for very dense, 100%(5/5).
References[1] Mammographic Density and the Risk and Detection of BreastCancer. Boyd et al, NEJM 2007:356:227-36M[2] Radar imaging of breast lesions – a clinical evaluation andcomparison. Shere et al, ECR 2016, Vienna[3] MARIA M4: clinical evaluation of a prototype ultrawidebandradar scanner for breast cancer detection. Preece et al, JMI, 2016,3(3)[4] Adjunct Screening With Tomosynthesis or Ultrasound inWomen With Mammography-Negative Dense Breasts: InterimReport of a Prospective Comparative Trial. Tagliafico et al, J. Clin.Oncology34, no. 16 (June 2016) 1882-1888.
Column1 Cases Sensitivity Score Mean age (years) Age range (years) Cysts (Sensitivity Score) Cancer (Sensitivity Score) Others (Sensitivity Score)
All 232 176 (76%) 50 16-81 62/82 (76%) 66/90 (73%) 48/60 (80%)
Pre-/ Peri-menopausal
163 121 (74%) 42 16-60 54/72 (75%) 27/39 (69%) 40/52 (77%)
Post- menopausal (inc HRT)
68 54 (79%) 68 49-81 8/10 (80%) 38/50 (76%) 8/8 (100%)
Lucent tissue (BIRADS a)
14 10 (71%) 67 40-81 N/A 7/10 (70%) 3/4 (75%)
Lucent tissue (BIRADS b)
56 37 (66%) 59 34-81 6/11 (55%) 26/37 (70%) 5/8 (63%)
Dense tissue (BIRADS c)
78 61 (78%) 50 19-80 32/41 (78%) 18/23 (78%) 11/14 (79%)
Dense tissue (BIRADS d)
32 27 (84%) 49 32-81 16/18 (89%) 5/5 (100%) 6/9 (67%)
BIRADS Unavailable
52 41 (79%) 39 16-72 8/12 (67%) 10/15 (67%) 23/25 (92%)
Figure 2: Sensitivity performance table for MARIA™ by BiRAD density, menopausal status and lesion type (cyst, cancer, other) for 232 single breast studies.
Right
Left
3 Dimensional ViewRight
(a) (b)
(c) (d)
(a) (b)
(e) (f)
(c) (d)3 Dimensional ViewLeft
(f)
3 Dimensional ViewRight
(e)
Figure 3: P107 Bilateral, Age 58, BiRAD ‘c’ (a, Right) MMG showing asymmetrical density of indeterminate nature in the UC (b, Left) MMG showing patchy irregular density suspicious of
malignancy in the central /medial (c, Right) US showing irregular mass suspicious of malignancy in the UC (d, Left) US showing lump at central breast extending above and below the left nipple (e,
Right) MARIA™ is showing cluster of scatters at CC/CI and one lesion at CO (f, Left) MARIA™ is showing two lesions at CO and LO
Figure 4: P130 Bilateral, Age 48, BiRAD ‘b’ (b, Left) MMG showing well-defined ovoid low-density opacity consistent with a simple cyst (a, Right) MMG showing area of segmental calcification which is indeterminate (c, Right) and (d, Left) US showing indefinite lesion found in each breast (e, Right)
MARIA™ showing 5 clusters of scatter in half of the outer CC area, (f, Left) MARIA™ showing six clusters of scatter in CC/CO/LC and one at upper left CC
