Breast Biopsy
Conditions
Brief summary
Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies
Interventions
DIAGNOSTIC_TESTneedle biopsy
breast biopsy using different needle gauges
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Comparison of 14 vs 16 gauge needles
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Minimum age of 18 years * Informed consent available * Palpable and non-palpable breast findings * Tumor size 5-20 mm * Findings of sonographic BI-RADS® classification 2-5. * Guideline-oriented indication for bioptic clarification
Exclusion criteria
* No reliable sonographic demarcation of the finding * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | 1 year | * Diagnostic aggreement (representativity) with definitive histology of core needle specimen and of surgical specimen * Additive diagnostic aggreement (representativity) with definitive histology of core needle specimen and with histology of surgical specimen, with 1 to 5 passes of core needle biopsy * Additive diagnostic accuracy to achieve a high (\>=99%) diagnostic yield, with 1-5 passes of core needle biopsy |
| Diagnostic quality | 1 year | * Diagnostic quality of specimen to achieve an accurate histological diagnosis * Diagnostic quality of specimen to achieve an accurate histological diagnosis, with 1 to 5 passes of core needle biopsy * Additive diagnostic quality to achieve a high (\>=99%) diagnostic yield, with 1-5 passes of core needle biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain related to the biopsy procedure | 1 year | Subjective pain perception measured visual analog scale |
| Duration time of the biopsy procedure | 1 year | Duration time of the biopsy procedure |
Countries
Germany
Outcome results
None listed