Purpose

Sentinel lymph node biopsy (SLNB) has been recognized as “the gold standard” for axillary staging in early breast cancer patients with clinically negative lymph nodes, resulting in significant morbidity decrease and quality of life improvement. This study aims to validate the performance of a newly developed handheld portable gamma camera (PGC) produced by Imagensys (Italy), in detecting and locating sentinel lymph nodes (SLNs) during the preoperative and intraoperative phases in breast cancer patients compared to conventional lymphoscintigraphy.

Methods

Adult female patients with histologically confirmed breast cancer, candidates for surgery and SLNB, were prospectively enrolled in this open-label, pre-marketing clinical trial. All patients underwent pre- operative assessment using both the PGC and conventional lymphoscintigraphy. The performance of the two devices was compared using the Poisson regression model for incidence rate ratios (IRRs). The intrinsic sensitivity of the devices was compared using the Wilcoxon Ranked Sign Test. The utility of PGC during intra-operative procedures was also evaluated. The manoeuvrability of the devices was evaluated using operator-satisfaction questioner.

Results

Sixty-eight patients (median age 50 years, BMI 21.4) were enrolled, including two patients with bilateral breast cancer, who underwent SLNB on both axillae. The PGC demonstrated superior preoperative lymph node detection rate (IRR 8.01, 95% CI 6.11–10.50; p < 0.0001) and intrinsic device sensitivity (mean counts per second 409 ± 286 vs. 255 ± 1173 for conventional device, p = 0.0003) compared to the conventional gamma camera. Intra-operative assessment with PGC was performed in 62 patients and no additional lymph nodes were visualised. However, the conventional gamma camera demonstrated superior manoeuvrability (p < 0.0001).

Conclusion

The PGC handheld gamma camera showed promising results for preoperative SLN assessment in patients with breast cancer. The limited manoeuvrability may be related to the operator’s experience leading to higher inter-operator variability. Appropriate training and frequent use of nuclear medicine and surgical equipment could overcome this limitation.

中文翻译：

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越小越好？紧凑型与传统伽马相机用于乳腺癌患者前哨淋巴结定位

 目的

前哨淋巴结活检 （SLNB） 已被公认为临床淋巴结阴性的早期乳腺癌患者腋窝分期的“金标准”，可显著降低发病率并改善生活质量。本研究旨在验证 Imagensys（意大利）生产的新开发的手持式便携式伽马相机 （PGC） 在乳腺癌患者术前和术中阶段检测和定位前哨淋巴结 （SLN） 的性能，与传统淋巴闪烁显像相比。

 方法

经组织学证实的乳腺癌成年女性患者，适合手术和 SLNB，前瞻性纳入这项开放标签的上市前临床试验。所有患者均使用 PGC 和常规淋巴闪烁显像进行了术前评估。使用发生率比 （IRR） 的泊松回归模型比较了两种设备的性能。使用 Wilcoxon Ranked Sign Test 比较设备的内在灵敏度。还评估了 PGC 在术中手术中的效用。使用操作员满意度提问器评估设备的可操作性。

 结果

纳入了 68 例患者 （中位年龄 50 岁，BMI 21.4），包括 2 例双侧乳腺癌患者，他们在双侧腋窝接受了 SLNB。PGC 显示出优异的术前淋巴结检出率 （IRR 8.01,95% CI 6.11-10.50;p < 0.0001）和固有器件灵敏度（每秒平均计数 409 ± 286 vs. 传统器件的 255 ± 1173，p = 0.0003）。 对 62 例患者进行了 PGC 术中评估，未观察到额外的淋巴结。然而，传统的伽马相机表现出优异的机动性 （p < 0.0001）。

 结论

PGC 手持式伽马相机在乳腺癌患者术前 SLN 评估方面显示出有希望的结果。有限的机动性可能与操作员的经验有关，导致操作员间的可变性更高。适当的培训和经常使用核医学和手术设备可以克服这一限制。