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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37670

Enrollment

120

Registered

2012-07-24

Start date

2012-11-21

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer breast carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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 technetium-99m enhanced SNL are the same.	—

Secondary

Measure	Time frame
Secondary outcomes - 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] - 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 - Preoperative concordance of microbubble and technetium-99m enhanced SLNs, imaged with SPECT/CT - Duration of procedures and hospitalization - Patients pain and comfort scores: microbubble-enhanced versus technetium-99m guided localization of SLN - Surgeon*s / radiologists preferences and opinions Tertiary outcomes For the subgroup of patients with non-palpable lesions, we will estimate the proportion of patients for whom plannable surgery could have been achieved. Here plannable surgery will be defined as successful preoperative localisation of both the primary tumor (image-guided Iodine-125 seed placement) and the sentinel node (microbubble-guided Iodine-125 seed placement).	—

Measure

Time frame

Secondary outcomes - 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] - 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 - Preoperative concordance of microbubble and technetium-99m enhanced SLNs, imaged with SPECT/CT - Duration of procedures and hospitalization - Patients pain and comfort scores: microbubble-enhanced versus technetium-99m guided localization of SLN - Surgeon*s / radiologists preferences and opinions Tertiary outcomes For the subgroup of patients with non-palpable lesions, we will estimate the proportion of patients for whom plannable surgery could have been achieved. Here plannable surgery will be defined as successful preoperative localisation of both the primary tumor (image-guided Iodine-125 seed placement) and the sentinel node (microbubble-guided Iodine-125 seed placement).

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Countries

Netherlands

Outcome results