ACRIN 6657: CONTRAST-ENHANCED BREAST CANCER MRI FOR EVALUATION OF PATIENTS

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 本试验的主要目的是使用肿瘤缓解的MRI测量值，从一组对新辅助化疗表现出部分或最小临床缓解（通过体格检查确定）的III期乳腺癌受试者中唯一识别出具有统计学差异的两组受试者。ACRIN 6657方案扩展的目的是研究在治疗过程早期通过1H MRS测量的总胆碱浓度[tCho]对预测病理反应的有用性。在完成原始6657方案的入组后，符合与原始方案相同合格性标准的另一组患者将入组方案扩展。对成像方案进行了三项变更：1）在MRI检查中增加了单体素1H MRS采集和可选的弥散加权MRI采集，2）在治疗过程中将（6657项研究相关）成像检查的数量从4项减少到3项，3）变更第1个周期后MRI/MRS检查的时间。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. The main objective of this trial is to use MRI measurements of tumor response to uniquely identify two groups of participants who have statistically different three-year disease-free survival out of a group of participants with Stage III breast cancer who demonstrate a partial or minimal clinical response (as identified by physical examination) to neoadjuvant chemotherapy. The objective of the ACRIN 6657 protocol extension is to investigate the usefulness of total choline concentration [tCho] measured by 1H MRS early in the course of treatment, for predicting pathologic response. Following completion of accrual to the original 6657 protocol, an additional group of patients meeting the same eligibility criteria as in the original protocol are being enrolled to the protocol extension. Three changes to the imaging protocol have been made: 1) addition of a single voxel 1H MRS acquisition and optional diffusion-weighted MRI acquisition to the MRI exam, 2) reduction of the number of (6657 study-related) imaging exams from 4 to 3 during the course of treatment, and 3) change of the timing of the post 1st cycle MRI/MRS exam.