NL-OMON37670
Completed
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
niversitair Medisch Centrum Utrecht0 sites120 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- breast cancer
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 2 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
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
ocalization of the sentinel node with microbubble contrast and Iodine-markersPatient with breast cancer with an indication for sentinel lymph node biopsyTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-000333-40-NLniversity Medical Center Utrecht120
Suspended
Not Applicable
Towards plannable breast surgery: Diagnostic accuracy of microbubble enhanced Iodine-125 seed localization of the sentinel lymph node.Breast cancer, sentinel lymph node localizationNL-OMON27431niversity Medical Center Utrecht, Department of Radiology120
Not yet recruiting
Not Applicable
Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuum-assisted bIopsy in breaST cancer after neoadjuvant chemotherapy: a multicenter, single-arm, non-inferiority trial [OPTIMIST trial]NeoplasmsKCT0007638Seoul National University Hospital533
Completed
Not Applicable
Improved diagnosis of clinically occult breast lesionsbreast neoplasmsbreast cancer10006291NL-OMON38092niversitair Medisch Centrum Utrecht128
Not yet recruiting
Not Applicable
The effect of pre-operative clothing on body temperature before, during and after breast surgeryPerioperative hypothermiaOther - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12609000546257Christchurch Hospital40