Trial document




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  DRKS00004755

Trial Description

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Title

Detection of microcalcifications in resected breast tissue with Flat-Panel CT (FPCT) : correlation with post-surgical mammographic, tomosynthesis and pathological findings

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Microcalcifications in breast tissue can be sign of a malignant tumor. In order to diagnose these cases early, it is recommended that women between the ages of 50 and 69 as well as women with suspicion for breast cancer undergo a two dimensional x-ray imaging known as mammography. If the mammography shows a tumor-suspicious legion, it is chirurgical excised. The operative specimen is subsequently examined using mammography to verify if the entire tissue region with microcalcifications was indeed removed. We would like to investigate if these operative specimens can be better examined using digital volume tomography (=cone beam computertomography).

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Brief Summary in Scientific Language

A digital volume tomograph (DVT) uses x-rays to generate high resolution 3-dimensional images. Following the standard examination of the operative specimen with mammography and tomosynthesis, we plan to also examine them with a DVT. The histological examination by pathologists follows as it normally would. The patients do not receive additional x-ray exposure since we only examine already excised tissue and the treatment plan is in no way influenced by the results of our DVT examination. With this study, we wish to correlate the results of our DVT examination with the results of the mammography and tomosynthesis and the results from pathology. We expect a better appraisal of the excised tissue with the high resolution 3-D imaging of a DVT, especially with the regard to the question of complete removal of the tissue with microcalcifications.

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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

  •   DRKS00004755
  •   2013/03/05
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  •   yes
  •   Approved
  •   507/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1139-5816 
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Health Condition or Problem studied

  •   Microcalcifications of breast tissue
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Interventions/Observational Groups

  •   Resected breast tissue is analyzed in mammography, tomosynthesis and DVT. This is followed by the regular pathologic diagnostics.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Detection of microcalcifications

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Secondary Outcome

None

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2015/11/25
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with breast lesions with microcalcifications that are being resected.

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Exclusion Criteria

Instantaneous section necessary.

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetterstraße
    • 49  Freiburg
    • Germany
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    • Gynäkologie Universitätsklinik Freiburg
    • Mr.  Prof. Dr.  Elmar  Stickeler 
    • Hugstetterstraße 49
    • 79095  Freiburg
    • Germany
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    • Radiologie Universitätsklinik Freiburg
    • Mr.  Dr.  Jakob  Neubauer 
    • Hugstetterstraße 49
    • 79095  Freiburg
    • Germany
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    • Radiologie Universitätsklinik Freiburg
    • Mr.  Dr.  Jakob  Neubauer 
    • Hugstetterstraße 49
    • 79095  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg
    • Hugstetterstraße 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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