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: 10333064
• 负责人: Sunil Singhal
• 金额: $ 44.04万
• 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/10333064
• 关键词: Address; Adjuvant; 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; Laparoscopy; Lesion; Localized Malignant Neoplasm; 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; Problem Solving; 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; 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.

项目摘要 该项目的主要目的是翻译近红外光学对比度的图像引导 支气管镜和手术。当发现患者患有肺结核时，这两个过程是 诊断支气管镜检查和治疗手术。但是，这两个程序困扰着 诸如区分癌性结节和非癌性结节等问题，发现第二 癌症，识别阳性边缘并进行准确的后桌病理评估。 因此，支气管镜检查和肺癌手术的成功率均约为60％。那里 是紧迫的未满足需要开发新的创新技术，可以帮助临床医生 定位癌细胞，描述肿瘤边缘以及鉴定微转移和排水淋巴 节点。我们提出了一项新技术，以在护理标准的支气管镜检查和 手术以识别癌性病变，在完成之前发现残留的局部疾病 程序，并进行诊断。虽然拟议的技术广泛适用于固体 肿瘤，该项目专门致力于改善对肺癌的检测，这是最多的。 积极的人类恶性肿瘤。为了实现这一目标，我们组建了一个合作团队 宾夕法尼亚大学具有临床试验，肺病理学，胸外科手术的协同专业知识， 和成像。拟议的工作将优化组合中的四种不同类型的对比剂 鸡尾酒，用于翻译术中成像临床试验。示踪剂组合将进行评估 在肺癌患者的首次人类临床试验中，以确定是否有好处 术中成像，用于护理标准的支气管镜检查和手术。组合对比剂 策略将使患病细胞更深入地埋在组织中。这将允许 精确的肿瘤定位和更准确的癌症切除，而无需违反肿瘤囊 或播种体腔。