None listed
Conditions
Brief summary
Breast cancer is the most common cancer for woman in New Zealand. An important aspect to the management of women with breast cancer is sentinel lymph node (SLN) biopsy. The SLN hypothesis is that migration of tumour cells from the primary tumour metastasizes to one or a few lymph nodes before involving the other lymph nodes. The current standard technique for SLN biopsy involves the use of radioisotope and/or blue dye tracers injected into the peri-tumour tissue, which will then enter lymphatic channels to passively flow to SLNs. SLNs infiltrated with the radioisotope will be identified using a hand-held probe which makes a loud noise and gives a high count on the probe monitor as it closes in on a ‘hot’ lymph node; SLNs infiltrated with the blue dye will appear unnaturally blue. There are some limitations, however, to the use of these tracers. The use of radioisotope requires nuclear medicine facilities, storage and handling protocols, specialised personnel who have undergone radiation safety education as well as the need for patients to present the day before surgery for injection of the tracer itself. These factors are particularly significant for provincial centres and/or patients living in more isolated areas. The blue dye also tattoos the skin that can sometimes last up to several months and is associated with severe anaphylactoid reactions in 0.1 to 1.1% of patients. More recently, a new technique for SLN biopsy has been developed using a magnetic superparamagnetic iron oxide tracer (SPIO), injected in a similar fashion to blue dye and localised intraoperatively using a handheld magnetic probe similar to the gamma probe. The SPIO tracer has been in use in clinical practice for over 20 years as intravenous contrast for MRI. The probe responds to the magnetic signal given off by the presence of the tracer. This will be a single centre pilot study conducted by the Breast Unit within the department of General Surgery at Auckland City Hospital. We will be trialling this new technique for sentinel lymph biopsy using magnetic tracer (Sienna) and its handheld magnetic localisation probe (SentiMag) in addition to the current standard technique (radioisotope and blue dye). The radiotracer and blue dye will be administered as per the current practice as well as the magnetic tracer. This pilot study will have the following feasibility aims and scientific aims. 1. Feasibility – recruitment: Can we recruit at a minimum one patient a week? 2. Feasibility – resources: What is the learning curve for this new technique for individual surgeons in our Unit? 3. Scientific – primary endpoint: proportion of successful procedures for SLN identification (identification rate per patient) by the magnetic method compared with the standard method (radioisotope and patent blue).
Interventions
The intervention is a new technique for sentinel node biopsy in breast cancer using magnetic superparamagnetic iron oxide tracer injection (Sienna+®). This tracer is injected (2ml) into the tumour by the operating surgeon in theatre after the patient has been placed under general anaesthetic. A specialised handheld magnetic probe (Sentimag®) is then used to localise the sentinel nodes that have taken up the magnetic tracer. The probe is an approximately 25cm thin cylindrical device that makes a
The intervention is a new technique for sentinel node biopsy in breast cancer using magnetic superparamagnetic iron oxide tracer injection (Sienna+®). This tracer is injected (2ml) into the tumour by the operating surgeon in theatre after the patient has been placed under general anaesthetic. A specialised handheld magnetic probe (Sentimag®) is then used to localise the sentinel nodes that have taken up the magnetic tracer. The probe is an approximately 25cm thin cylindrical device that makes a noise when it is close to the magnetic tracer. It is similar to the standard technique currently used when radioisotope is injected and a handheld gamma probe is used, the probe making a noise when it is close to the radioisotope tracer. For study participants they are not aware of the use of these probes as they are under General Anaesthetic. The duration of the procedure can vary from 20minutes to an hour depending on how difficult it is to localise the sentinel node. The two techniques (using sentimag and the standard technique currently used) are performed simultaneously.
Sponsors
Mr Isaac Cranshaw
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All women over the age of 18 undergoing sentinel node biopsy for breast cancer (invasive or ductal carcinoma, or extensive ductal carcinoma in-situ) with clinically and radiologically node-negative axillae will be eligible to participate.
Exclusion criteria
Exclusion criteria include patients with allergy to iron or dextran compounds, iron overload disease, pacemaker or ferrous metal-containing devices in the chest wall, pregnancy and lactation.
Outcome results
None listed