Division of Thoracic Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Division of Thoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.
Ann Thorac Surg. 2021 Oct;112(4):1150-1159. doi: 10.1016/j.athoracsur.2020.09.037. Epub 2020 Nov 19.
Intraoperative molecular imaging (IMI) may improve surgical outcomes during pulmonary resection for lung cancer. A multiinstitutional phase 2 IMI clinical trial was conducted using a near-infrared, folate receptor-targeted contrast agent for lung adenocarcinomas, OTL38. The primary goal was to determine whether OTL38 improved surgeons' ability to identify difficult to find nodules, occult cancers, and positive margins.
Patients with lung nodules received OTL38 (0.025 mg/kg) preoperatively. Patients had IMI sequentially during lung inspection, tumor resection, and margin check. Efficacy was evaluated by occurrence of clinically significant events, occurrences that caused the surgeon to modify the operation or upstage the patient's cancer. Safety was assessed for a single intravenous dose of OTL38.
Of 110 patients recruited, 92 were eligible for analysis. During lung inspection, IMI found 24 additional nodules, 9 (10%) of which were cancers that had not been known preoperatively. During tumor resection, IMI located 11 (12%) lesions that the surgeon could not find. During the margin check, IMI revealed 8 positive margins (9%) that the surgeon thought were negative. Benefits of IMI were pronounced in patients undergoing sublobar pulmonary resections and in patients with ground-glass opacities. There were no serious adverse events. All surgeons felt comfortable with the procedures by 10 cases.
In this phase 2 clinical trial, IMI improved outcomes for 26% of patients. A randomized, multiinstitutional phase 3 clinical trial is underway.
术中分子成像（IMI）可能改善肺癌肺切除术中的手术结果。进行了一项多机构的 IMI 临床试验，使用近红外、叶酸受体靶向对比剂用于肺腺癌 OTL38。主要目标是确定 OTL38 是否提高外科医生识别难以发现的结节、隐匿性癌症和阳性切缘的能力。
肺结节患者术前接受 OTL38（0.025mg/kg）。患者在肺检查、肿瘤切除和边缘检查时进行 IMI 检查。通过临床显著事件的发生来评估疗效，这些事件导致外科医生修改手术或升级患者的癌症分期。评估单次静脉注射 OTL38 的安全性。
110 名患者中，92 名符合分析条件。在肺检查期间，IMI 发现了 24 个额外的结节，其中 9 个（10%）是术前未知的癌症。在肿瘤切除期间，IMI 定位了 11 个（12%）外科医生找不到的病变。在边缘检查中，IMI 显示 8 个（9%）外科医生认为是阴性的阳性切缘。IMI 在亚肺叶切除和磨玻璃混浊患者中获益明显。没有严重的不良事件。所有外科医生在 10 例后都对这些操作感到满意。
在这项 2 期临床试验中，IMI 改善了 26%的患者的结果。一项随机、多机构的 3 期临床试验正在进行中。
