NOVEL TARGETED RADIOPHARMACEUTICAL FOR TUMOR IMAGING

这项II期研究的目的是对一种新的 叶酸靶向放射性药物，111 In-DTPA-叶酸，用于放射性核素 显像 具体目的是：1）制备111 In-DTPA-叶酸 按照cGMP生产和包装的放射性药物试剂盒 要求; 2）进行卵巢癌I/II期临床研究 患者评价111 In-DTPA-叶酸的安全性和可能的疗效 对原发性和转移性卵巢癌进行成像; 3）启动 肺腺癌患者的I/II期临床研究， 评价111 In-DTPA-叶酸用于成像的安全性和可能的有效性 原发性和转移性肺腺癌; 4）汇编和分析 第一阶段和第二阶段的数据与市场分析相结合， 决定进行III期临床试验是否科学 商业价值。 目的1的研究将在cGMP进行 生产和包装设施;目标2研究将在 德克萨斯大学医学博士安德森癌症中心;以及关于目标3的研究 将在芝加哥大学医学中心进行。 这些 研究旨在评估111 In-DTPA的临床潜力- 叶酸作为叶酸受体阳性的放射性核素显像剂 肿瘤的

The objective of this Phase II study is the clinical evaluation of a novel folate-targeted radiopharmaceutical, 111In-DTPA-folate, for radionuclide imaging. The Specific Aims are: 1) To generate 111In-DTPA-folate radiopharmaceutical kits manufactured and packaged in accordance with cGMP requirements; 2) to conduct a phase I/II clinical study in ovarian cancer patients to evaluate the safety and possible efficacy of 111In-DTPA-folate for imaging primary and metastatic ovarian carcinoma; 3) to initiate a Phase I/II clinical study in lung adenocarcinoma cancer patients to evaluate the safety and possible efficacy of 111In-DTPA-folate for imaging primary and metastatic lung adenocarcinoma; 4) compilation and analysis of Phase I and Phase II data integrated with market analysis to reach a decision whether proceeding to Phase III clinical trials is scientifically and commercially merited. Studies on Aims 1 will be performed at cGMP production and packaging facilities; studies on Aim 2 will be performed at the University of Texas MD Anderson Cancer Center; and studies on Aim 3 will be performed at the University of Chicago Medical Center. These studies are designed to evaluate the clinical potential of 111In-DTPA- folate as a radionuclide imaging agent for folate receptor positive tumors.