肺癌术中应用Abenacianine进行分子成像的多中心II期临床试验
Phase II Multicenter Clinical Trial of Intraoperative Molecular Imaging with Abenacianine During Lung Cancer Surgery.
作者
作者单位
- Orlando Health Cancer Institute, Orlando, FL, USA.
- St. Vincent's Hospital, Melbourne, Australia.
- City of Hope National Medical Center, Duarte, CA, USA.
- Mayo Clinic, Rochester, MN, USA.
- University of Texas MD Anderson Cancer Center, Houston, TX, USA.
- Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. sunil.singhal@pennmedicine.upenn.edu.
摘要
中文
手术是局部肺癌治疗的基石，然而术中面临的挑战包括准确的病灶定位及手术切缘评估。术中分子成像（IMI）采用近红外荧光引导手术，是一种实时靶向肿瘤的光学成像技术。一项多中心II期临床试验评估了abenacianine（VGT-309），一种组织蛋白酶靶向的近红外IMI药物，用于术中肺结节及切缘的可视化。主要目标为评估abenacianine的疗效。在6个中心，预定接受肺部已知或疑似肿瘤手术的患者于术前12–36小时静脉给予abenacianine 0.32 mg/kg。疗效通过具有临床意义事件的比例衡量，定义为：标准手术技术未能定位的病灶定位、额外癌灶的识别、切缘不足的组织学确认以及癌性淋巴结的检出。在89例接受abenacianine及手术切除的患者中，40例（45%）至少发生一例具有临床意义的事件。abenacianine联合近红外成像在33例（37%）患者中识别出标准方法未发现的病灶，在3例（3%）患者中发现术前影像未检出的同时性及隐匿性癌灶，在8例（9%）患者中发现距最近切割线10 mm以内的切缘，在1例（1%）患者中检出癌性淋巴结。abenacianine在本研究中安全且耐受性良好，未发生与药物相关的严重不良事件。在标准肺癌手术中应用abenacianine进行IMI可改善术中定位、隐匿病灶识别、切缘评估及淋巴结检出，从而实现更完整的肿瘤学切除。
English
Surgery is the cornerstone for locally contained lung cancer; however, intraoperative challenges include accurate lesion localization and assessment of surgical margins. Intraoperative molecular imaging (IMI) using near-infrared fluorescence-guided surgery is a real-time tumor-targeted optical imaging technique. A multicenter phase II clinical trial evaluated abenacianine (VGT-309), a cathepsin-targeted near-infrared (NIR) IMI agent for visualization of pulmonary nodules and margins during surgery. The primary objective was to assess the efficacy of abenacianine. At six sites, patients scheduled to undergo surgery for known or suspected cancer in the lung received intravenous abenacianine 0.32 mg/kg 12-36 h before surgery. Efficacy was measured by the proportion of clinically significant events, defined as localization of lesions not found by standard surgical techniques, identification of additional cancers, identification of inadequate surgical margins confirmed by histology, and detection of cancerous lymph nodes. Of 89 patients who received abenacianine and surgical resection, 40 (45%) had at least one clinically significant event. Abenacianine with NIR imaging identified lesions not found by standard methods in 33 (37%) patients, synchronous and occult cancers not found by preoperative imaging in three (3%) patients, margins within 10 mm of the closest staple line in eight (9%) patients, and cancerous lymph nodes in one (1%) patient. Abenacianine was safe and well-tolerated in this study; there were no drug-related serious adverse events. IMI with abenacianine during standard-of-care lung cancer surgery improved intraoperative localization, identification of occult lesions, margin assessment, and lymph node detection, enabling a more complete oncologic resection.
分类与指标
- 研究类型
- 临床研究
- 病种
- 肺癌
- JCR 分区
- Q1
- 影响因子
- 3.8
- 新锐分区
- 2区