Rice David, Singhal Sunil, Niemeyer Emma, Sarkaria Inderpal, Martin Linda W, Ebright Michael I, Louie Brian E, Lee Tommy, Predina Jarrod D
MD Anderson Cancer Center, Houston, Texas.
Center for Precision Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Ann Thorac Surg. 2025 Aug;120(2):294-301. doi: 10.1016/j.athoracsur.2024.10.001. Epub 2024 Oct 21.
Clinical studies have demonstrated that intraoperative molecular imaging (IMI) with pafolacianine identifies occult pulmonary lesions that are not identified by preoperative computed tomography or by intraoperative inspection techniques in ∼20% of patients. This study describes occult lesion clinical data and evaluates characteristics so that surgeons can better incorporate this emerging technology into clinical decision making.
Participants (n = 100) enrolled in a phase 3 trial of IMI with pafolacianine during pulmonary resection (Enabling Lung Cancer Identification Using Folate Receptor Targeting [ELUCIDATE]; NCT04241315) were identified. Participants underwent preoperative computed tomography with 1.25-mm slices. Patient and lesion characteristics were analyzed. Positive predictive value and false positive rates were tabulated for IMI fluorescent lesions, with predictors of malignant vs benign occult lesions described.
IMI identified 29 occult lesions in 23 (23%) participants. Seventeen of 29 (58%) lesions were identified within the same lobe as known lesions; 12 of 29 (42%) were identified in a different lobe from the suspicious nodule known by preoperative assessment. Twenty-three of 29 (79%) of occult lesions found by IMI were resected with an additional wedge resection. Ten of 29 (34%) lesions identified by IMI were malignant. There was no additional morbidity in participants with lesions resected. With pafolacianine, 7 participants had a synchronous primary stage I lung cancer identified, and 1 participant had additional metastases identified.
IMI with pafolacianine identifies occult malignant lesions during pulmonary resection despite thorough preoperative imaging and intraoperative assessment by experienced surgeons.
临床研究表明，使用帕福拉新的术中分子成像（IMI）可识别出约20%的患者中术前计算机断层扫描或术中检查技术未发现的隐匿性肺部病变。本研究描述了隐匿性病变的临床数据并评估其特征，以便外科医生能够更好地将这项新兴技术纳入临床决策。
确定了参与帕福拉新IMI在肺切除术中的3期试验（使用叶酸受体靶向技术实现肺癌识别[ELUCIDATE]；NCT04241315）的参与者（n = 100）。参与者接受了层厚为1.25毫米的术前计算机断层扫描。分析了患者和病变特征。列出了IMI荧光病变的阳性预测值和假阳性率，并描述了隐匿性恶性病变与良性病变的预测因素。
IMI在23名（23%）参与者中识别出29处隐匿性病变。29处病变中有17处（58%）在与已知病变相同的肺叶内被识别；29处中有12处（42%）在术前评估已知的可疑结节所在肺叶以外的不同肺叶中被识别。IMI发现的29处隐匿性病变中有23处（79%）通过额外的楔形切除术被切除。IMI识别出的29处病变中有10处（34%）为恶性。切除病变的参与者未出现额外的并发症。使用帕福拉新时，7名参与者被发现患有同步原发性I期肺癌，1名参与者被发现有额外转移灶。
尽管术前进行了全面的影像学检查且经验丰富的外科医生进行了术中评估，但使用帕福拉新的IMI仍可在肺切除术中识别出隐匿性恶性病变。
