Whole-Body PET/CT Assessment of Tumor Perfusion Using Generator-Produced 62Cu

描述(由申请人提供)：该项目将评估一种使用发电机生产的铜-62评估肿瘤血流灌注的非侵入性PET方法。建议的方法将适合在美国的任何临床PET中心实施，补充目前用于评估肿瘤代谢的临床全身PET 18F-FDG研究。该项目的临床重点是头颈部癌症患者，文献证据表明，肿瘤血流灌注测量可以预测治疗反应。接受同步放化疗的局部或局部晚期头颈癌患者将接受研究用的62CuETS放射性药物，用于“全身”PET/CT成像，以评估肿瘤的血流情况。62Cu-ETS成像将在18F-FDG标准基线和治疗后临床PET/CT之前立即进行。还将使用150度水对一组患者进行成像，以提供肿瘤血流灌注的独立参考测量。62Cu-ETS肿瘤灌注结果将使用图像衍生的动脉输入功能进行量化。肿瘤血流灌注的全球和区域测量将与18F-FDG成像的结果以及使用RECIST标准的肿瘤大小的变化进行比较。受试者将在治疗完成后一个月进行随访；然后至少每三个月进行一次。成像结果将与临床结果的独立指标进行相关性检验，包括24个月精算局部无进展存活率、区域无进展存活率、无远处转移存活率和总存活率。治疗失败将被定义为经活检证实的复发疾病，或成像结果与除疾病复发或转移以外的任何其他解释不一致。放化疗后计划的颈淋巴清扫术显示残留的活肿瘤细胞将不被归类为区域性失败，因为这将被认为是计划的根治性治疗的完成。该项目既需要并利用比例技术公司正在开发的放射性制药生产技术，也需要普渡大学药学院和印第安纳大学医学院的学术合作者的专业知识。公共卫生相关性：头颈部癌症约占美国成人恶性肿瘤的3%，对非裔美国人的影响不成比例。该项目启动了对PET成像方法的临床评估，以评估肿瘤血流，使用的成像技术可以很容易地在全国各地的医疗中心实施。这种PET方法有望提高医生为头颈癌患者做出最佳治疗决定的能力。

DESCRIPTION (provided by applicant): This project will evaluate a non-invasive PET method for assessment of tumor perfusion using generator- produced copper-62. The proposed method will be suitable for implementation at any clinical PET center in the U.S., complementing current clinical whole-body PET 18F-FDG studies to assess tumor metabolism. The project's clinical focus is patients with head-and-neck cancer, where literature evidence indicates that tumor perfusion measurements can be predictive of response to therapy. Patients with localized or locally advanced head and neck cancer, who are to receive concurrent chemo-radiation therapy, will receive the investigational 62Cu-ETS radiopharmaceutical for "whole-body" PET/CT imaging to assess tumor perfusion. The 62Cu-ETS imaging will occur immediately prior to scheduled standard baseline and post-therapy clinical PET/CT with 18F-FDG. A subset of patients will also be imaged using 15O-water to provide an independent reference measure of tumor perfusion. The 62Cu-ETS tumor perfusion results will be quantified using an image-derived arterial input function. Global and regional measures of tumor perfusion will be compared to the findings from 18F- FDG imaging, as well as to changes in tumor size using RECIST criteria. Subjects will be seen for follow-up one month after completion of treatment; then a minimum of every three months. The imaging results will be examined for correlations with independent measures of clinical outcome, including twenty-four month actuarial local progression-free survival, regional progression-free survival, distant metastases-free survival and overall survival. Therapy failure will be defined as biopsy-proven recurrent disease, or imaging results inconsistent with any other explanation than disease recurrence or metastases. Planned neck dissection following chemo-radiotherapy showing the presence of residual viable tumor cells will not be classified as regional failure, as this will be considered completion of the planned curative therapy. The project both requires, and exploits, radiopharmaceutical production technologies under development by Proportional Technologies, Inc., and the expertise of academic collaborators from the Purdue University School of Pharmacy and the Indiana University School of Medicine. PUBLIC HEALTH RELEVANCE: Head and neck cancers account for about 3% of adult malignancies in the United States, and disproportionately affect African Americans. This project initiates clinical evaluation of a PET imaging method to evaluate tumor blood flow, using imaging technology that can be readily implemented at medical centers throughout the country. This PET method is expected to improve the physician's ability to make optimal treatment decisions for head and neck cancer patients.