Breast Cancer Clinical Trial
Official title:
First Use of a Hybrid Gamma Camera for Sentinel Lymph Node Localisation in Patients Undergoing Surgery for Primary Breast Cancer
A novel hand held hybrid optical-gamma camera (hereinafter referred to as the "camera") has been developed and can be used to image radiotracer distribution at the patient bedside. This study aims to evaluate the imaging capabilities of the camera in patients attending surgery for sentinel lymph node biopsy (SLNB) procedure. It is anticipated that this could improve the accuracy and simplify sentinel lymph node detection by providing fused optical and gamma imaging.
This is a single centre prospective, non-randomised and non-blinded research project using
the camera in the operating theatre in addition to the standard gamma surgical probe for
assessing lymph node involvement in breast cancer patients undergoing surgery for their
disease. The duration of the study is 1 year.
The purpose of the trial will be to determine if the camera can be used for the localisation
of sentinel lymph nodes during the SLNB procedure and to compare detection rates of sentinel
lymph node(s) with the standard method using the gamma probe.
Study Plan:
This study will not alter the standard SLNB procedures provided by the healthcare provider.
The camera will be used to acquire images in the axillary and parasternal regions as
additional steps to the standard SLNB procedures. No invasive actions are performed. Images
obtained using the camera in this study will include gamma, optical and fused gamma/optical
images in each acquisition. In additional to the intraoperative imaging study using the
camera system, a subjective assessment by questionnaire will be carried out amongst the
surgeons to obtain their feedback.
Statistics:
For the quantitative analysis, the distribution of continuous variables will be summarised
using mean and standard deviation (if normally distributed) or median and range (if not
normally distributed); distribution of categorical variables will be summarised by
presenting the number and percentages that falling into each categories. Missing data will
be recorded. SPSS will be used to manage the data. The detection rate of both detection
methods (camera versus standard techniques) will be tabulated as binary data (yes/no).
Validity analysis will be computed for sensitivity, specificity, positive predictive value
and negative predictive value. Also Kappa (categorical data) method will be used to examine
the agreement between two methods. Good agreement will be claimed if the value of kappa
between 0.81 and 1.00.
Sample size:
The calculated sample size is 53 participants. It has been calculated using nQuery Advisor®
6.0 with the goal to make conclusion using agreement. The sample size has the 80% power to
pick up ҡ1 = 0.410 or greater.
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