La imagen colposcópica es subjetiva y poco sensible

Chase DM, et al. Colposcopy to evaluate abnormal cervical cytology in 2008. Am J Obstet Gynecol. 2009 May;200(5):472-80.

El examen colposcópico es complejo y requiere habilidades.

Variaciones inter-observador e intra-observador: 52% concordancia inter-observevador.

65% concordancia intra-observervador.

Walker JL, et al. Predicting absolute risk of CIN3 during post-colposcopic follow-up: results from the ASCUS-LSIL Triage Study (ALTS). Am J Obstet Gynecol. 2006 Aug;195(2):341-8.

CH3-C(=O)-

H+

Acetic Acid in solution

Normal Cells

1. Cell walls of normal tissue will prevent transfer of hydrogen or acetate ions

C2H4O2 Dysplasia Cells in Lactic Acid

2. Intracellular space of dysplastic tissue contains lactic acid that causes recombination of acetic acid, which can then pass through cell walls

CH3-C(=O)- H+

Reflected White Light

3. Once inside the cell, the acetate ion reacts with cell nucleus changing its light reflective properties

In Vivo Molecular Imaging of Cervical Intra-Epithelial Neoplasia, C Balas, IEEE Vol 14, Jan 2008

• Colposcopia Digital computerizada

• Asistencia diagnóstica por software

• Creación de un mapa en tiempo real que

cuantifica el grado de las imágenes

• Localización de sitios de biopsia

• Base de datos de imágenes y video

• Standard examination process • High Resolution imaging • Acetic acid used as normal

2-3 mins

• Sequential images captured

• Dynamic Spectral analysis performed on each pixel (proprietary algorithms)

• Cellular response is measured • Characteristic curves relate to

tissue status at each pixel • DySISmap is generated

CIN1

CIN2

CIN3

Time

Dif

fuse

Ref

lect

ance

oDySISmap for improved diagnosis and sensitivity

oCIN3

oCIN2

oCIN1

oHPV

oInflammation

oLow-grade

oHigh-grade

oExtreme

oStrong

oModerate

oMild

DySISmap colour Aceto-whitening Level Cervical Neoplasia PAP Smear Grade

El mapeo DySIS es un código de colores sobre el cérvix que marca: Localización Márgenes Grado de las lesiones

Reduce la subjetividad Reduce la incertidumbre

Biopsy markers placed by clinician based on observed aceto-whitening

(#4 is a random control point).

DySISmap analysis of the same, showing the original biopsy markers – note the errors in the marker positions.

DySISmap assists in accurate biopsy location selection and

biopsy execution.

Clinical Trial Results

The results showed that DySIS has a higher sensitivity than conventional colposcopy

Soutter et al, Clinical Cancer Research 2009

308 women participated in a prospective, comparative, clinical trial conducted in three colposcopy clinics: two in London and one in Athens. The DySISmap was compared to colposcopic impression and referral cytology in identifying HG patients The sensitivity of conventional colposcopy to correctly identify women with high-grade neoplasia was 49%; the sensitivity of the DySISmap was 79%. DySIS detected an additional 22 (57 total) women with HG lesions.

49%

79%

Conventional colposcopy

DySISmap

sensitivity

275 women participated in a prospective, comparative, clinical trial conducted in three colposcopy clinics in the Netherlands. The sensitivity of conventional colposcopy to correctly assess women with high-grade neoplasia was 55%; the sensitivity of the DySISmap™ was 79%.

55%

79% 88%

Conventional colposcopy

DySISmap Conventional colposcopy plus DySISmap

The study showed that when the conventional colposcopic assessment of high-grade patients was combined with the DySISmap™ the sensitivity reached 88%.

Louwers, et al, Dynamic Spectral Imaging Colposcopy: Higher sensitivity for detection of premalignant cervical lesions, BJOG 2011

Clinical Trial Results

sensitivity

Zaal A, et al. BJOG. 2012 Feb 3. doi: 10.1111/j.1471-0528.2012.03280.x. [Epub ahead of print]

N=177

N=102

83,3 82,3 83,8

71,8

90,5 90,6 85,3

90,2 85,3

92,6 88,3

73,5

95,6 98,3

87,8

0

20

40

60

80

100

120

Precisión S E VPP VPN

Colpo DySIS Colo+DySIS

9 casos

111 casos. 102 en cérvix

77,8

100

66,7 60

100

55,6

66,7

50

40

75

0

20

40

60

80

100

120

Precisión S E VPP VPN

Colpo DySIS

Ninguna

Experiencia

Poca Mucha

P<0,001 P<0,001

50 preguntas

22 encuestas

Colposcopia DySIS Valor p

Aciertos

Media

Mediana

44%

22.1

21.0

52%

25.8

25.5

0.001

DySIS

0

5

10

15

20

25

30

35

40

45

50

Poco deacuerdo

2 3 4 Muy deacuerdo

Más Fácil

Orient Dx

Orient Bx

Más inform

Poca Exp

Mejor

0

20

40

60

80

100

120

Más fácil Orient Dx Orient Bx Más info Poca exp Mejor

Ninguna

Poca

Mucha

P=0,033

I. DySIS mejora algo la sensibilidad de la colposcopia

II. Útil en la orientación diagnóstica y elección de la biopsia

III. Más intuitivo y menos subjetivo que la colposcopia

IV. Bien valorado por los ginecólogos menos expertos