ocalization of the sentinel node with microbubble contrast and Iodine-markers

• Conditions: Patient with breast cancer with an indication for sentinel lymph node biopsy; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000333-40-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-24
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• 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;

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.

* 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: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if microbubble-enhanced localization of the SLN, followed by I-125 seed placement, is an accurate tool for preoperative identification of the SLN in women with invasive or in situ breast cancer in terms of diagnostic accuracy, sensitivity and technical feasibility ;Secondary Objective: To evaluate if microbubble-enhanced localization of the SLN, followed by I-125 seed placement, is superior to Tc-99m enhanced SLN biopsy in terms of patient comfort (pain), duration of procedure and preference of the surgeon and radiologist. ;Primary end point(s): Detection rate of microbubble-enhanced Iodine-125 seed localization of SLN, defined as the number of patients in whom the microbubble-enhanced SLN and the Tc-99m enhanced SNL are the same.;Timepoint(s) of evaluation of this end point: After completion of the trial

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: After completion of the trial;Secondary end point(s): - Sensitivity of microbubble-enhanced I-125 seed localization: [number of patients with microbubble detected metastatic SLNs] / [total number of patients with axillary lymph node metastases].<br>- Technical feasible microbubble-enhanced I-125 seed localization of SLN: successful visualization of SLN, successful I-125 seed placement and excision of I-125 seed without migration or seed loss. <br>- Preoperative concordance of microbubble and Tc-99m enhanced SLNs, imaged with SPECT/CT.<br>- Duration of procedures and hospitalization. <br>- Patients pain and comfort scores: microbubble-enhanced versus Tc-99m guided localization of SLN.<br>- Surgeon’s / radiologists preferences and opinions.<br>