Department of Chemistry, The University of Texas at Austin.
Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
JAMA Netw Open. 2024 Mar 4;7(3):e242684. doi: 10.1001/jamanetworkopen.2024.2684.
Surgery with complete tumor resection remains the main treatment option for patients with breast cancer. Yet, current technologies are limited in providing accurate assessment of breast tissue in vivo, warranting development of new technologies for surgical guidance.
To evaluate the performance of the MasSpec Pen for accurate intraoperative assessment of breast tissues and surgical margins based on metabolic and lipid information.
DESIGN, SETTING, AND PARTICIPANTS: In this diagnostic study conducted between February 23, 2017, and August 19, 2021, the mass spectrometry-based device was used to analyze healthy breast and invasive ductal carcinoma (IDC) banked tissue samples from adult patients undergoing breast surgery for ductal carcinomas or nonmalignant conditions. Fresh-frozen tissue samples and touch imprints were analyzed in a laboratory. Intraoperative in vivo and ex vivo breast tissue analyses were performed by surgical staff in operating rooms (ORs) within 2 different hospitals at the Texas Medical Center. Molecular data were used to build statistical classifiers.
Prediction results of tissue analyses from classification models were compared with gross assessment, frozen section analysis, and/or final postoperative pathology to assess accuracy.
All data acquired from the 143 banked tissue samples, including 79 healthy breast and 64 IDC tissues, were included in the statistical analysis. Data presented rich molecular profiles of healthy and IDC banked tissue samples, with significant changes in relative abundances observed for several metabolic species. Statistical classifiers yielded accuracies of 95.6%, 95.5%, and 90.6% for training, validation, and independent test sets, respectively. A total of 25 participants enrolled in the clinical, intraoperative study; all were female, and the median age was 58 years (IQR, 44-66 years). Intraoperative testing of the technology was successfully performed by surgical staff during 25 breast operations. Of 273 intraoperative analyses performed during 25 surgical cases, 147 analyses from 22 cases were subjected to statistical classification. Testing of the classifiers on 147 intraoperative mass spectra yielded 95.9% agreement with postoperative pathology results.
The findings of this diagnostic study suggest that the mass spectrometry-based system could be clinically valuable to surgeons and patients by enabling fast molecular-based intraoperative assessment of in vivo and ex vivo breast tissue samples and surgical margins.
手术切除完整的肿瘤仍然是乳腺癌患者的主要治疗选择。然而，目前的技术在提供体内乳房组织的准确评估方面存在局限性，需要开发新的技术来进行手术指导。
评估 MasSpec Pen 基于代谢和脂质信息，对乳房组织和手术切缘进行准确的术中评估的性能。
设计、地点和参与者：在这项 2017 年 2 月 23 日至 2021 年 8 月 19 日期间进行的诊断性研究中，使用基于质谱的设备分析了来自接受乳房手术的成年患者的健康乳房和浸润性导管癌 (IDC) 银行组织样本，这些患者患有导管癌或非恶性疾病。新鲜冷冻组织样本和触摸印痕在实验室中进行分析。手术人员在德克萨斯医学中心的 2 家不同医院的手术室 (OR) 中进行术中体内和体外乳房组织分析。分子数据用于构建统计分类器。
通过与大体评估、冷冻切片分析和/或最终术后病理比较，对组织分析的预测结果进行评估，以评估准确性。
纳入统计分析的是来自 143 个银行组织样本的所有数据，包括 79 个健康乳房和 64 个 IDC 组织。数据呈现了健康和 IDC 银行组织样本的丰富分子谱，观察到几种代谢物的相对丰度有显著变化。统计分类器在训练、验证和独立测试集上的准确率分别为 95.6%、95.5%和 90.6%。共有 25 名参与者参加了临床、术中研究；均为女性，中位年龄为 58 岁（IQR，44-66 岁）。术中技术的测试由手术人员在 25 次乳房手术中成功完成。在 25 例手术中的 273 次术中分析中，22 例中的 147 次分析进行了统计分类。对 147 个术中质谱的分类器测试结果与术后病理结果的一致性为 95.9%。
这项诊断性研究的结果表明，基于质谱的系统通过实现对体内和体外乳房组织样本和手术切缘的快速基于分子的术中评估，对外科医生和患者可能具有重要的临床价值。
