breast neoplasms
Conditions
Interventions
The studied diagnostic intervention is a vacuum assisted percutaneous intact
biopsy of mammographically suspicious breast lesions under stereotactic
mammographic guidance. The intervention will be p
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Female gender; - Age >= 18 years; - Nonpalpable mammographically suspicious breast lesion (classified as BIRADS 3-5) requiring stereotactic biopsy.
Exclusion criteria
Exclusion criteria: - Legal incapability; - Insufficient command of the Dutch language; - Contraindication for temporarily stopping anticoagulant therapy; - Inability to maintain a prone position for 1 hour; - Ipsilateral breast implant; - Lactation; - Implanted electronic device;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histological diagnosis issued on the biopsy specimen and the surgical excision specimen, the number of cancelled procedures due to a contra-indication for RFIB and the number of unsuccessful RFIB procedures due to technical failure or a nonrepresentative biopsy sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| A numerical pain score, procedure duration, cosmetic outcome and functional status post RFIB, complication rate, biopsy specimen quality and the chance of complete removal of a lesion. | — |
Countries
Netherlands
Outcome results
None listed