Towards plannable breast surgery: diagnostic accuracy of microbubble enhanced Iodine-125 seed localization of the sentinel lymph node (MIB study)

Completed

• Conditions: breast cancer; breast carcinoma; 10006291; 10006295

• Registration Number: NL-OMON37670
• 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: 120

Inclusion Criteria

- Females, aged 18 years or older
- Histologically confirmed invasive carcinoma or patients with in situ breast cancer with indication for SLN biopsy

Exclusion Criteria

- Male patients
- Histologically or cytologically proven axillary lymph node involvement
- Recurrent disease
- Indication for ALND
- Pregnancy or lactation
- Sentinel lymph node biopsy after neoadjuvant treatment
- Recent acute coronary syndrome or unstable ischemic heart disease*
- Severe lung disease* and shortness of breath
- Unstable neurologic disease, acute endocarditis, artificial heart valves, acute systemic infection, tromboembolic disease, advanced liver or kidney failure
- Mentally incompetent patients;* SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg, uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome. Caution is advised when SonoVue is administered to patients with clinically significant pulmonary disease, including severe chronic obstructive pulmonary disease.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Detection rate of microbubble-enhanced Iodine-125 seed localization of SLN,<br /><br>defined as the number of patients in whom the microbubble-enhanced SLN and the<br /><br>technetium-99m enhanced SNL are the same. </p><br>