Abstract
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Objectives To compare the performances of the hand-held camera POCI with conventional gamma camera (GM) lymphoscintigraphy (LS) for sentinel lymph nodes (SLN) detection in breast cancer (BC).
Methods To demonstrate the noninferiority of POCI relative to conventional LS and to compare the number of SLNs detected by the two devices. A clinical prospective, double-blind, non inferiority study was planned to include 200 patients (pts) with early breast cancer. A standard SLN protocol was performed preoperatively using a conventional triple-head GC and then the POCI camera. The scans were carried out by two different nuclear medicine physicians blinded to each other’s results. The day after, in operating room, the surgeon, blinded to the results of both GC and POCI results, first used POCI to perform an intra-operative LS then used the counting probe for surgical SLNs biopsy. The number and the localization of axillary SLNs obtained by conventional GC and POCI were confronted as well as duration of acquisition times.
Results Among the 162 pts included 138 are evaluable. In comparison to LS POCI detected more SLNs in 50 pts (36%), same number in 54 pts (39%) and less SLNs in 34 pts (25%) which represented 84 (61%) discordant pairs. POCI’s noninferioriy of axillary SLNs numbers was achieved (95% CI 30-52% and p = 0,025) according to predefined criteria (Noninferiority margin of 5% and lower CI limit of 55%) by Mac Nemar modified test for noninferiority. Duration of acquisition was shorter using POCI lasting less than 10 minutes in 84% (n=117) of pts (Mean + SD : 7.5 min. + 3.3) versus 13% (n=18) only with conventional LS (Mean + SD :15.7 min. + 3.4) with p<0,001.
Conclusions POCI hand-held camera was able to predict number and localization of BC SLNs and was not inferior to conventional LS. POCI is a reliable tool to replace standard GC, specially in surgical centers without on-site nuclear medicine department
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