Project 1: Clinical Trials in Intraoperative Molecular Imaging of Non-Small Cell Cancer

项目1：非小细胞癌术中分子影像临床试验

• 批准号: 10647641
• 负责人: Sunil Singhal
• 金额: $ 38.28万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-16 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10647641
• 关键词: Acceleration; Address; Adjuvant Therapy; American; Applications Grants; Back; Binding; Biopsy; Bronchoscopy; Cancer Patient; Cancerous; Cells; Clinic; Clinical; Clinical Trials; Colonoscopy; Colposcopy; Contrast Media; Cystoscopy; Deposition; Detection; Devices; Diagnosis; Diagnostic; Disease; Dose; Endoscopy; Equipment; Esophagoscopy; Excision; FOLR1 gene; Genomics; Goals; Grant; Histologic; Histology; Human; Image; Image-Guided Surgery; Imaging Device; Individual; Infusion procedures; Institution; Laparoscopy; Lesion; Localized Disease; Location; Lung; Lung nodule; Malignant Neoplasms; Malignant neoplasm of lung; Measures; Medical Imaging; Micrometastasis; Motion; Near-infrared optical imaging; Nodule; Non-Small-Cell Lung Carcinoma; Operating Rooms; Operative Surgical Procedures; Optics; Pathologic; Patient imaging; Patients; Penetration; Pennsylvania; Phase; Polyps; Predictive Value; Procedures; Pulmonary Pathology; Resectable; Resected; Residual Cancers; Residual state; Resolution; Second Primary Cancers; Series; Solid Neoplasm; Specificity; Specimen; Staging; Surgeon; Technology; Testing; Therapeutic; Thoracic Surgical Procedures; Time; Tissues; Tracer; Translating; Translations; Universities; Validation; Visual; Work; body cavity; cancer cell; cancer surgery; capsule; clinical application; diagnostic accuracy; draining lymph node; experience; first-in-human; flexibility; healthy volunteer; image guided; improved; innovation; innovative technologies; lymph nodes; molecular imaging; new technology; novel; operation; optical imaging; radiological imaging; receptor; respiratory; standard of care; success; tumor; wound bed

Project Summary The primary goal of this Project is to translate near-infrared optical contrast agents for image-guided bronchoscopy and surgery. When a patient is found to have a lung nodule, the two procedures are a diagnostic bronchoscopy and a therapeutic surgery. However, these two procedures are plagued with problems such as discriminating between cancerous and non-cancerous nodules, finding second cancers, identifying positive margins, and performing an accurate back table pathological assessment. Therefore, the success rate for bronchoscopy and surgery for lung cancer are both around 60%. There are urgent unmet needs to develop new and innovative technologies that can assist the clinician in localizing cancer cells, delineating tumor margins, and identifying micrometastases and draining lymph nodes. We propose a new technology to image patients during standard-of-care bronchoscopy and surgery in order to identify cancerous lesions, to discover residual local disease before completing the procedure, and to render a diagnosis. While the proposed technologies are broadly applicable to solid tumors, this project is specifically committed to improving detection of lung cancer, one of the most aggressive human malignancies. To accomplish this goal, we have assembled a collaborative team at University of Pennsylvania with synergistic expertise in clinical trials, lung pathology, thoracic surgery, and imaging. The proposed work will optimize four distinct types of contrast agents in a combination or cocktail for a translational intraoperative imaging clinical trials. The tracer combination will be evaluated in a first-in-human clinical trial of lung cancer patients in order to determine if there is a benefit of intraoperative imaging to standard-of-care bronchoscopy and surgery. The combination contrast agent strategy will allow better imaging of diseased cells more deeply buried in the tissues. This will allow for precise tumor localization and more accurate resection of cancers without violating the tumor capsule or seeding the body cavity.

项目概要 该项目的主要目标是将近红外光学造影剂转化为图像引导 支气管镜检查和手术。当患者发现有肺结节时，这两个程序是 诊断性支气管镜检查和治疗性手术。然而，这两个过程都存在问题 诸如区分癌性结节和非癌性结节等问题，找到第二个 癌症，识别阳性切缘，并进行准确的后台病理评估。 因此，支气管镜检查和肺癌手术的成功率均在60%左右。那里 迫切需要开发新的创新技术来帮助临床医生 定位癌细胞、描绘肿瘤边缘、识别微转移和引流淋巴液 节点。我们提出了一种新技术，可以在标准护理支气管镜检查过程中对患者进行成像， 手术以识别癌性病变，在完成手术之前发现残留的局部疾病 程序，并做出诊断。虽然所提出的技术广泛适用于固体 肿瘤，该项目专门致力于改善肺癌的检测，肺癌是最常见的癌症之一 侵袭性人类恶性肿瘤。为了实现这一目标，我们组建了一个协作团队 宾夕法尼亚大学在临床试验、肺病理学、胸外科、 和成像。拟议的工作将优化四种不同类型的造影剂的组合或 用于转化术中成像临床试验的鸡尾酒。将评估示踪剂组合 在一项针对肺癌患者的首次人体临床试验中，以确定是否有益处 术中成像到标准护理支气管镜检查和手术。组合造影剂 该策略将能够更好地对埋藏在组织深处的病变细胞进行成像。这将允许 在不侵犯肿瘤包膜的情况下实现精确的肿瘤定位和更准确地切除癌症 或在体腔内播种。