Improved diagnosis of clinically occult breast lesions

Completed

• Conditions: breast neoplasms; breast cancer; 10006291

• Registration Number: NL-OMON38092
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 128

Inclusion Criteria

- Female gender;
- Age >= 18 years;
- Nonpalpable mammographically suspicious breast lesion (classified as BIRADS 3-5) requiring stereotactic biopsy.

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;

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Histological diagnosis issued on the biopsy specimen and the surgical excision<br /><br>specimen, the number of cancelled procedures due to a contra-indication for<br /><br>RFIB and the number of unsuccessful RFIB procedures due to technical failure or<br /><br>a nonrepresentative biopsy sample. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A numerical pain score, procedure duration, cosmetic outcome and functional<br /><br>status post RFIB, complication rate, biopsy specimen quality and the chance of<br /><br>complete removal of a lesion. </p><br>