Clinical Evidence in the EU

DySIS has been tested in two independant large, multi-centre clinical studies.

The clinical effectiveness of using DySIS has been tested in two international multi-center clinical trials. More clinical work is in progress, but the highlights of those published results are summarised below:

In 2009, Soutter et al, published their results in the Clinical Cancer Research journal; 308 women were examined in the three participating clinics after they had been referred for colposcopy. All women were examined by DySIS which was used concomitantly for the DySIS mapping and for conventional colposcopy. The colposcopists who did not have access to the DySISmap during the examination, missed 37 out of the 72 patients with high-grade disease, achieving a sensitivity of just 49%. The comparison between colposcopic impression and the DySISmap is compelling; the DySISmap picked up 22 patients with high-grade (CIN2+) disease that were missed by the colposcopists, and reached a sensitivity of 79%.

In the beginning of 2011, Louwers et al published the results of another study on DySIS, that was carried out in three colposcopy clinics in the Netherlands, using the first commercially available version of DySIS. Their results confirmed the findings of the first trial, as the DySISmap was again significantly more sensitive in picking up high-grade patients than conventional colposcopy. More importantly, the design of this trial allowed answering the more clinically relevant question; “what is the sensitivity that can be reached by using DySISmap as an additional data source in the colposcopic exam?”. The results demonstrated a sensitivity of 88%. Therefore, clinicians using all the information that is relevant for the evaluation of the condition of a cervix during an examination with DySIS, should expect a significant increase in their harvesting of high-grade patients.

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Soutter et all, CCR 2009

Link to journal: http://clincancerres.aacrjournals.org/content/15/5/1814

Abstract

Purpose:

Colposcopy occupies a key role in the prevention of cervical cancer by identifying preinvasive or invasive lesions. However, colposcopy is subjective and is responsible for 52% of screening failures. Dynamic spectral imaging (DSI) is based on the objective, quantitative assessment of the acetowhitening effect.This study compared DSI with colposcopy.

Experimental Design:

Women referred for colposcopy were examined simultaneously with colposcopy and DSI using a precommercial DySIS model (FPC-03) in an international, multicenter trial. The colposcopy impression and DySIS values were compared with consensus histology reports of biopsies. Subjects were recruited to a training group and subsequently to a test group. Measures were taken to avoid verification bias.

Results:

The training and test groups comprised 82 and 308 eligible women, respectively. A cutoff value to identify high-grade disease was selected from the results of the training group and data from previous work. Receiver operator curve analysis of the test data showed an area under the curve of 0.844. DySIS detected 62.9% more high-grade cases than colposcopy (57 versus 35, P = 0.0001). DySIS exceeded end points approved by the Food and Drug Administration for similar studies, with increments in the true positive rate of 22/308 (7.1%; lower 95% CL, 4.5% versus 2%) and in the false positive rate of 32/308 (10.4%; upper 95% CL, 14.7% versus 15%).

Conclusions:

DySIS is more sensitive than colposcopy in detecting high-grade lesions and can provide improved guidance for biopsy. The results are obtained in a user-independent fashion, making it suitable for use by nursing personnel.

Louwers et al, BJOG 2011

Link to journal: http://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.2010.02806.x/abstract

Abstract

Objective:

To validate the dynamic spectral imaging (DSI) colposcope’s colour-coded map in discriminating high- from low-grade cervical lesions and non-neoplastic tissue.

Design:

Prospective, comparative, multicentre clinical trial.

Setting:

The colposcopy clinics of three Dutch hospitals.

Population:

Women of 18 years or over with an intact cervix, referred for colposcopy.

Methods:

During a 3-minute image acquisition phase, the DSI colposcope was used as a regular video colposcope: the colposcopist located and graded potential lesions based on conventional colposcopic criteria. Subsequently, a colour-coded map was calculated and displayed, representing localisation and severity of the cervical lesion. Biopsies were collected from all atypical sites, as identified by digital mapping and/or conventional colposcopy. Furthermore, one additional biopsy was taken.

Main outcome measures:

Histologically confirmed high-grade cervical disease (CIN2+).

Results:

In total 275 women were included in the study: 183 women were analysed in the ‘according-to-protocol’ (ATP) cohort and 239 women in the ‘intention-to-treat’ (ITT) cohort. In the ATP cohort, the sensitivity of DSI colposcopy to identify women with high-grade (CIN2+) lesions was 79% (95% CI 70–88) and the sensitivity of conventional colposcopy was 55% (95% CI 44–65) (P = 0.0006, asymptotic McNemar test). When the DSI colour-coded map was combined with conventional colposcopy, the sensitivity was 88% (95% CI 82–95).

Conclusions:

DSI colposcopy has a significantly higher sensitivity to detect cervical lesions than conventional colposcopy. If the colour-coded map is combined with conventional colposcopic examination, the sensitivity increases further.