NOVEL TARGETED RADIOPHARMACEUTICAL FOR TUMOR IMAGING

这项第二阶段研究的目标是对一种新的 用于放射性核素的叶酸靶向放射性药物111In-DTPA-叶酸 成像。具体目标是：1)生成111In-DTPA-叶酸 根据cGMP制造和包装的放射性药物试剂盒 要求；2)进行卵巢癌的I/II期临床研究 患者评估111In-DTPA-叶酸的安全性和可能的疗效 用于原发和转移性卵巢癌的成像；3)启动 肺腺癌患者的I/II期临床研究 评价111In-DTPA-叶酸显像的安全性和可能的有效性 原发癌和转移性肺腺癌；4)汇编和分析 第一阶段和第二阶段数据与市场分析相结合，以达到 决定是否进行第三阶段临床试验是科学的 在商业上也是值得的。对AIMS 1的研究将在cGMP进行 生产和包装设施；目标2的研究将在 德克萨斯大学MD安德森癌症中心；以及AIM 3的研究 将在芝加哥大学医学中心演出。这些 研究旨在评估111In-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。

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.