EUCTR2012-000333-40-NL
Active, not recruiting
Not Applicable
Towards plannable breast surgery: diagnostic accuracy of microbubble enhanced Iodine-125 seed localization of the sentinel lymph node (MIB study) - Microbubbles and Iodine seeds in Breast cancer: MIB study
ConditionsPatient with breast cancer with an indication for sentinel lymph node biopsyTherapeutic area: Diseases [C] - Cancer [C04]
DrugsSonoVue
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patient with breast cancer with an indication for sentinel lymph node biopsy
- Sponsor
- niversity Medical Center Utrecht
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Females, aged 18 years or older;
- •\- Histologically confirmed invasive carcinoma or patients with in situ breast cancer with indication for SLN biopsy;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 80
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 40
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.
Outcomes
Primary Outcomes
Not specified
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