Trial document





This trial has been registered retrospectively.
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  DRKS00012625

Trial Description

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Title

Assessment of breast lesion size and characterization: correlation of
cone-beam breast-CT, digital breast tomosynthesis, full-field digital mammography with histopathological examination of mastectomy specimens

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

To assess breast lesions on mastectomy specimens with different imaging techniques, including mammography, tomosynthesis and breast computed-tomography compared to pathological analyses, in order to determine which imaging technique is the best for size assessment and lesion characterisation.

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Brief Summary in Scientific Language

To compare the accuracy of breast lesion size measurement of cone-beam breast-CT (CBBCT), digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) with histopathological gold standard on mastectomy specimens.

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Organizational Data

  •   DRKS00012625
  •   2017/07/06
  •   [---]*
  •   yes
  •   Approved
  •   2/12/14, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Imaging of mastectomy specimens by full-field digital mammography (FFDM), digital breast tomosynthesis (DBT) and cone-beam breast-CT (CBBCT) and histopathological assessment of breast lesions.
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Characteristics

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

Measurement (in millimeter) of breast lesions by FFDM, DBT and CBBCT immediately after mastectomy via a radiologist. Lesion size was measured in coronary orientation.
Immediate histological fixation of the mastectomy specimen, histopathological size measurement of breast lesions (in millimeter) within a few days via a pathologist.

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Secondary Outcome

Characterisation of breast lesions with the aforementioned imaging modalities in comparison to histopathology.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/03/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients scheduled for mastectomy due to at least one biopsy-proven malignant breast lesion.

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Exclusion Criteria

Age under 18 years and prophylactic mastectomy.

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Addresses

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    • University Medical Center Goettingen
    • Ms.  Dr. med.  Susanne  Wienbeck 
    • Robert-Koch-Strasse 40
    • 37075  Goettingen
    • Germany
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    • University Medical Center Goettingen
    • Ms.  Dr. med.  Susanne  Wienbeck 
    • Robert-Koch-Strasse 40
    • 37075  Goettingen
    • Germany
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    • University Medical Center Goettingen
    • Ms.  Dr. med.  Susanne  Wienbeck 
    • Robert-Koch-Strasse 40
    • 37075  Goettingen
    • Germany
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Sources of Monetary or Material Support

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    • University Medical Center Goettingen
    • Ms.  Dr. med.  Susanne  Wienbeck 
    • Robert-Koch-Strasse 40
    • 37075  Goettingen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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.