Trial document




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  DRKS00021136

Trial Description

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Title

Evaluation of the diagnostic benefit of contrast-enhanced spectral mammography compared to digital mammography and breast MRI to characterize intraductal breast cancer (DCIS) - ways to avoid over-therapy?

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Trial Acronym

CESM_DCIS

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URL of the Trial

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Brief Summary in Lay Language

Breast cancer is the most common cancer in women in Germany. The most common type of breast cancer is invasive ductal breast cancer. Mammography is currently the established standard method in breast cancer screening. In some cases, it can be supplemented or replaced by magnetic resonance imaging (MRI), also called "nuclear spin". As is well known, mammography often leads to so-called false-positive results due to a lack of specificity. These show no tumor involvement as proven after tissue sampling by biopsy and subsequent histopathological examination ("gold standard").
In the study, a new imaging diagnostic method is to be tested, the contrast-enhanced spectral mammography. It's ability to display ductal carcinoma in situ (DCIS) - one of the most common precancerous stages of breast cancer - is examined here. The diagnostic accuracy of contrast-enhanced mammography in the diagnosis of DCIS compared to breast MRI and standard mammography with the final histology as a reference is to be tested within the scope of this study.

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Brief Summary in Scientific Language

In breast cancer diagnostics, it would be very helpful to be able to assess whether it is a low-grade or a higher-grade DCIS and to know the exact size and extent (pre-therapy). So far, this has not been possible with the established methods (conventional digital mammography, breast MRI and breast sonography). About 45% of DCIS are occult in mammography and about 15% in breast MRI. MRI is superior to mammography in the diagnosis of DCIS, however it has so far not been possible to determine the grading in terms of image morphology. A better detection of the higher grade DCIS was described, but there were also study results in which the low and medium grade DCIS could be detected better than the higher grade. Since published data suggest that higher-grade DCIS in mammography can be better detected using the calcifications in the extent and increased perfusion is regarded as the basis for better detection on MRI, it can be expected that the combination of imaging of the calcifications and blood flow of the DCIS allows conclusions to be drawn about the grading.
The contrast medium-enhanced spectral mammography represents a promising alternative. It can be carried out with little additional time, equipment and personnel compared to conventional mammography and a time saving compared to breast MRI. The slightly higher x-ray exposure compared to conventional mammography is still below the established mammography quality standard. Risks associated with the administration of contrast medium correspond to those of a computed tomographic distant metastasis staging.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00021136
  •   2020/03/20
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  •   yes
  •   Approved
  •   596/2019BO1, 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

  •   D05 -  Carcinoma in situ of breast
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Interventions/Observational Groups

  •   Patients diagnosed with DCIS (ductal carcinoma in situ) as part of a biopsy. In addition to standard mammography, they receive a contrast-enhanced mammography of both breasts as well as a breast MRI. A study-related blood sample is taken to determine the creatinine and TSH value, which are required for contrast medium mammography (creatinine and TSH value) and breast MRI (creatinine value).
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Characteristics

  •   Interventional
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  •   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

Analysis of the diagnostic significance of contrast-enhanced spectral mammography compared to non-enhanced digital mammography and breast MRI in the detection and characterization of intraductal breast cancer (DCIS) depending on the tissue differentiation.
Patients who introduce themselves to the university clinic for gynecology or radiology with suspected breast cancer and who are diagnosed for a DCIS after a punch biopsy or who are already presenting themselves with externally secured DCIS can be included in the study. They will receive the imaging study examinations on two visits. Sensitivity, specificity, positive and negative predictive value of mammography, breast MRI and contrast medium mammography are calculated and compared with the final histology as the gold standard after the surgery.

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Secondary Outcome

• Do the size and number of DCIS manifestations or breast density influence the diagnostic accuracy of contrast-enhanced mammography?
• Does breast MRI provide additional benefit for contrast-enhanced mammography? Is a possible incremental value of breast MRI dependent on MR background enhancement?
• Can contrast-enhanced mammography be used to obtain additional clinically relevant parameters in patients with DCIS?
• Are there options for optimizing the examination procedure for contrast medium mammography?
• Is the low-energy image of contrast medium-enhanced mammography comparable to conventional digital mammography?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/08/01
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

• DCIS proven after punch biopsy
• Age ≥18 years
• written consent from the patient

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Exclusion Criteria

• patients unable to give their consent
• pregnant and breastfeeding patients
• contraindication against iodinated contrast medium
• contraindication against contrast agent containing gadolinium
• implants that are not MR-compatible and / or metals in / on the body
• hearing impairment or increased sensitivity to loud noises
• limited sensation of temperature and / or increased sensitivity to body warming
• claustrophobia
• exclusion criteria according to radiation protection ordinance

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Addresses

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    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Frauenklinik
    • Mr.  Prof. Dr.  Markus  Hahn 
    • Calwerstrasse 7
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Radiologische Klinik, Abt. für Diagnostische & Interventionelle Radiologie
    • Ms.  Dr.  Heike  Preibsch 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Radiologische Klinik, Abt. für Diagnostische & Interventionelle Radiologie
    • Ms.  Dr.  Heike  Preibsch 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Tübingen, Radiologische Klinik, Abt. für Diagnostische & Interventionelle Radiologie
    • Ms.  Dr.  Heike  Preibsch 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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    • GE Healthcare
    • 283 rue de la Miniäre
    • 78538   Buc Cedex 11
    • France
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Status

  •   Recruiting planned
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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.