Breast Cancer
Conditions
Keywords
breast cancer, lymph node, 99mTc, ICG
Brief summary
This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.
Detailed description
Pre-implementation: standard sentinel node procedure using 99mTc-nanocolloid, which implies 99mTc injection the day or the morning before surgery. Transition period: participating surgeons will receive on-site training, proctoring, and ongoing guidance from experienced surgeons and early adopters of the ICG method from St. Antonius Hospital, Utrecht, The Netherlands until they achieve confidence and proficiency in using ICG for SLNB. Post-implementation: 5 mg (2 ml) ICG will be injected periareolar after administration of general anesthesia and before incision. The SLN will be visualized by fluorescent imaging using a fluorescence camera. Main study endpoints: Primary endpoint is the identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG. Secondary endpoints are total number of LNs removed, detection time, total operative time, complications and (serious) adverse events, loco regional recurrence after 1 year follow-up, pre-implementation expectations regarding ICG, post-implementation experiences regarding ICG including barriers and success factors.
Interventions
PROCEDUREICG used as a tracer for sentinel lymph node
ICG used as a tracer for sentinel lymph node instead of technetium 99
PROCEDUREtechnetium 99 used as a tracer for sentinel lymph node
technetium 99 used as a tracer for sentinel lymph node instead of ICG
Sponsors
Casa di Cura Dott. Pederzoli
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The golden standard for obtaining the sentinel lymph node (SLN) in patients with breast cancer currently is radio guided surgery with radioisotope technetium (99mTc). However, the use of 99mTc-nanocolloid presents logistical challenges and contributes to patient burden. A proven effective and safe alternative is fluorescence imaging using indocyanine green (ICG).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinically node-negative, DCIS or invasive stage T1-T3 breast cancer confirmed by biopsy * Preoperative axillary ultrasound to confirm clinical node-negative status * Indication for breast cancer surgery with SLNB via axillar incision * Written informed consent according to national regulations
Exclusion criteria
* Patients \< 18 years old. * Indication for breast cancer surgery with SLNB via mastectomy incision * Known allergy for ICG, intravenous contrast or iodine * History of axillary lymph node dissection * Pregnancy or breast-feeding * Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG | through study completion, an average of 1 year | measure the percentage of sentinel lymph nodes identified by the 99mTc nanocolloid or the ICG fluorescent signal (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of SLNs that has 99mTc uptake/ is fluorescent | through study completion, an average of 1 year | Percentage of sentinel lymph nodes that have an absorption of 99mTc and are fluorescent (%) |
| Detection time | through study completion, an average of 1 year | Detection time is defined as time between skin incision and SLN resection in minutes (min) |
| Total operative time | through study completion, an average of 1 year | Registration of the duration of the total surgical procedure including the SN-procedure (min or h) |
| Number of complications and (serious) adverse events | through study completion, an average of 1 year | registration of the number of serious adverse events and complications, including seroma, wound infection and bleeding |
| loco regional recurrence after 1 year follow-up | through study completion, an average of 1 year | number of regional loco recurrences assessed through clinical examinations |
| The pathology of SLNs identified | through study completion, an average of 1 year | number of micro and macro metastases and isolated tumor cells (ITCs) |
Countries
Italy
Outcome results
None listed