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?

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? - CESM_DCIS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021136

Enrollment

150

Registered

2020-03-20

Start date

2020-09-30

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D05

Interventions

Group 1: 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 bre

Eligibility

Sex/Gender

Female

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • DCIS proven after punch biopsy • Age =18 years • written consent from the patient

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
• 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?	—

Measure

Time frame

• 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?

—

Countries

Germany

Contacts

Public ContactHeike Preibsch

Universitätsklinikum Tübingen, Radiologische Klinik, Abt. für Diagnostische & Interventionelle Radiologie

heike.preibsch@med.uni-tuebingen.de07071-2968626

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026