Non-inferiority Study of Mammography With the Contrast Medium (Contrast-enhanced Digital Mammography, CEDM) Versus Breast Magnetic Resonance (MRI)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The general objective of the study is to verify the diagnostic accuracy of contrast-enhanced mammography (CEM) compared to breast magnetic resonance imaging in patients undergoing preoperative staging for breast neoformations that have already been diagnosed and in patients undergoing neoadjuvant chemotherapy. In addition to performing a preoperative breast resonance imaging, which is always performed in these patients, one contrast-enhanced mammography per patient is planned. In patients undergoing neoadjuvant chemotherapy, which usually undergo MRI examination at the beginning, mid-cycle and at the end of chemotherapy treatment, a CEM will also be acquired same way at the beginning, mid-cycle and at the end of chemotherapy treatment. The study requires, for the execution of the contrast-enhanced mammography exam, the administration of an iodinated contrast medium that is completely analogous to that used in computed tomography.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Healthy Volunteers: f
View:

• women in pre-hospitalization with already established invasive breast cancer (T1-2)

• over the age of 30

• with BI-RADS mammography pattern\> 1

• Written and signed informed consent for research

• Negative history of adverse events to the use of iodinated and chelated contrast media of gadolinium

• No significant renal impairment (EGFR\> 30 mL / min within three months before administration of the iodinated contrast medium)

Locations
Other Locations
Italy
Ospedale Borgo Trento, AOUI Verona
RECRUITING
Verona
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 216
Treatments
Experimental: Patients undergoing preoperative staging and patients undergoing chemotherapy
All participants in the group 1 and 2 will undergo a routine clinical MRI followed by CEM during a scheduled visit.~In group 2 (neoadjuvant chemotherapy), patients will also undergo interim imaging with both MRI and CEDM at 3 and 6 months to assess treatment response.
Related Therapeutic Areas
Sponsors
Collaborators: GE Healthcare
Leads: Azienda Ospedaliera Universitaria Integrata Verona

This content was sourced from clinicaltrials.gov