Contrast-enhanced MR imaging of the breast at 7T and 3T in the same patients.

Contrast-enhanced MR imaging of the breast at 7T and 3T in the same patients. - 7T vs. 3T Breast MRI study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40016

Enrollment

Registered

2011-08-09

Start date

2012-06-25

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

breast cancer breast neoplasm

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 years or older Female patients A BI-RADS 4 or higher classification for a lesion detected at mammography and/or ultrasound

Exclusion criteria

Exclusion criteria: Surgery or radiotherapy to the ipsilateral breast up to one year before inclusion Prior treatment with chemotherapy Karnofsky score

Design outcomes

Primary

Measure	Time frame
To assess the diagnostic performance of 7T CE Breast MRI in comparison with the clinical standard of 3T MRI (by using the BI-RADS MRI lexicon) and histopathology, on a intra-individual basis.	—

Secondary

Measure	Time frame
- To assess the diagnostic performance of 7T versus 3T on a per lesion basis. - To assess the correlation of 7T MRI lesion size to 3T MRI lesion size and to lesion size determined on histopathology after surgery.	—

Countries

Netherlands

Outcome results