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?
Not Applicable
Recruiting
- Conditions
- D05Carcinoma in situ of breast
- Registration Number
- DRKS00021136
- Lead Sponsor
- niversitätsklinikum Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 150
Inclusion Criteria
• DCIS proven after punch biopsy
• Age =18 years
• written consent from the patient
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>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.<br><br>
- Secondary Outcome Measures
Name Time Method • Do the size and number of DCIS manifestations or breast density influence the diagnostic accuracy of contrast-enhanced mammography?<br>• Does breast MRI provide additional benefit for contrast-enhanced mammography? Is a possible incremental value of breast MRI dependent on MR background enhancement?<br>• Can contrast-enhanced mammography be used to obtain additional clinically relevant parameters in patients with DCIS?<br>• Are there options for optimizing the examination procedure for contrast medium mammography?<br>• Is the low-energy image of contrast medium-enhanced mammography comparable to conventional digital mammography?