Trial document




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  DRKS00013486

Trial Description

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Title

Hyperspectral imaging for contactless diagnosis of intraepithelial and invasive neoplasias

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Trial Acronym

Hyperspectral

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URL of the Trial

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Brief Summary in Lay Language

Dysplasia of the cervix is ​​a cell change that, over time, can develop into a malignant cancer of the cervix and should be detected early. This scientific research project is concerned with the contactless presentation and early detection of the earliest tissue changes ("degeneration") of the female reproductive organs by means of so-called "hyperspectral imaging".
Patients with the clinical suspicion of intraepithelial or invasive neoplasia of the female reproductive organs are included

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Brief Summary in Scientific Language

Invasive carcinomas of the mucous membranes of female genitalia are serious cancer entities and are usually associated with poor prognosis. Intraepithelial neoplasias are precursors of cancer in the development towards invasive carcinomas. Therefore, the early detection of cancer is of particular importance. Through comprehensive cancer screening in Germany, the incidence of carcinomas of the female reproductive organs was drastically reduced. Associated with the development of intraepithelial neoplasia are often single and persistent infections with human papillomavirus (HPV). In particular, high-risk HPV types 16 and 18 are responsible for the development of moderate and high-grade intraepithelial neoplasia and for the development of, for example, 60-70% of invasive cervical carcinomas. Likewise HPV-associated lesions are condylomas behind which the Bethesda system can hide "low-grade squamous intraepithelial lesions".
For example, guideline-based cancer screening in the cervix area places the highest quality demands on diagnostic instruments and the examiner. How different cancer detection is generally managed, Mitchell et al. in a meta-analysis, where only 9 out of 86 studies met the criteria of quality and statistical evaluability. The sensitivity of the cancer screening tests was between 85-96%, but the specificity only 48-70%. More recent studies confirm these results. However, innovative methods of standardizing and automating the investigation, which automatically and reproducibly assist the treating physicians in the diagnosis, are currently mostly vacant. The treatment decision for borderline colposcopic results could be positively influenced by such methods. Tidy et al. In a multicentric prospective study, supporting biosensory methods - here a tissue impedance measurement - significantly increased the sensitivity and specificity of early detection of CIN. Previous studies on the optically assisted detection of CIN have mostly depended on the application of a tracer substance such as acids or fluorescent substances.
Hyperspectral Imaging is already successfully used for the inspection and follow-up of wound healing processes and is an established method in industrial compound testing and quality assurance. Hyperspectral Imaging can be used for contactless and non-invasive analysis of functional, molecular and chemical parameters. Hyperspectral imaging takes place without contact and without the use of contrasting substances or medications. Various studies have already demonstrated the suitability of hyperspectral imaging for the detection of dysplastic tissue.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013486
  •   2017/12/05
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  •   yes
  •   Approved
  •   650/2017BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   intraepithelial and invasive neoplasms
  •   N87 -  Dysplasia of cervix uteri
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Interventions/Observational Groups

  •   hyperspectral imaging of intraepithelial or invasive neoplasia of the female reproductive organs
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Determination of specificity and sensitivity of hyperspectral imaging

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Secondary Outcome

Estimate the specificity and sensitivity of the iodine-acid analyses in this collective for comparison.
Estimation of the positive and negative predictive value of hyperspectral imaging

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/12/19
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Clinical / histological evidence of intraepithelial or invasive neoplasia
• Written agreement after clarification

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Exclusion Criteria

missing signed informed agreement

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Addresses

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    • Forschungsinstitut für FrauengesundheitDepartment für Frauengesundheit
    • Calwerstrasse 7
    • 72076  Tübingen
    • Germany
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    • Department für Frauengesundheit
    • Mr.  Dr.  Martin  Weiss 
    • Calwerstraße 7
    • 72076  Tübingen
    • Germany
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    • Department für Frauengesundheit
    • Mr.  Dr.  Martin  Weiss 
    • Calwerstraße 7
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Forschungsinstitut für FrauengesundheitDepartment für Frauengesundheit
    • Calwerstrasse 7
    • 72076  Tübingen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.