ACRIN 6684

<p>The objective of the ACRIN 6684 multi-center clinical trial was to determine the association of baseline FMISO PET uptake (maximal tumor to blood ratio, hypoxic volume) and MRI parameters (K<sup>trans</sup>, CBV) with overall survival, time to disease progression, and 6-month progression free survival in participants with newly diagnosed <em>glioblastoma multiforme </em>(GBM). The trial also collected standard brain cancer data such as Karnofsky performance status, but also pathological biomarkers that included MGMT status, HIF1-alpha, GLUT1, CAIX, CD31, and alpha-SMA expression assays. </p><p>There are two sets of volumes of interest (VOI) included with the ACRIN 6684 collection of MRI, PET and low-dose CT patient images.  These include delineation of enhancing brain tumor lesions and <sup>18</sup>F-FMISO PET hypoxia maps.  More information about these masks can be found on the Detailed Description tab below.  Additional information about the trial is available in the <a href="/wp-content/uploads/ACRIN-6684.pdf" download="ACRIN-6684.pdf" data-linked-resource-container-id="33948305" data-linked-resource-container-version="59" data-linked-resource-content-type="application/pdf" data-linked-resource-default-alias="ACRIN 6684.pdf" data-linked-resource-id="145753920" data-linked-resource-type="attachment" data-linked-resource-version="2" data-nice-type="PDF Document">Study Protocol</a> and <a href="/wp-content/uploads/ACRIN-6684_CRF-Set.pdf" download="ACRIN-6684_CRF-Set.pdf" data-linked-resource-container-id="33948305" data-linked-resource-container-version="59" data-linked-resource-content-type="application/pdf" data-linked-resource-default-alias="ACRIN 6684_CRF Set.pdf" data-linked-resource-id="145753921" data-linked-resource-type="attachment" data-linked-resource-version="2" data-nice-type="PDF Document">Case Report Forms</a>. </p><h3><strong>ACRIN 6684 Study Protocol</strong></h3><p>After establishing eligibility and enrollment to the study, baseline imaging of both MR and PET was performed within 2 weeks of starting therapy. FMISO, has been helpful in evaluating tumor oxygenation status, which may affect how well it responds to radiation and chemotherapy. The MRI scans were designed to measure tumor characteristics related to oxygenation status, including changes in blood flow, blood volume, and blood vessel size.</p><p>In the original protocol, following baseline imaging was an optional test-retest scan for FMISO PET only. Also included were PET and MRI scans at 3 weeks after the onset of chemo/radiation therapy, and 4 weeks following the end of standard treatment. Of the 50 patients enrolled in the study only one patient had a test-retest FMISO scan, and the requirement of scans mid and post therapy were dropped after the 4<sup>th</sup> case.  The current protocol appears in the figure on the right, and can be found online (<strong> <a href="https://www.acrin.org/Portals/0/Protocols/6684/ACRIN6684_Amend7_012412_master_ForOnline.pdf">Protocol-ACRIN 6684 Amendment 7, 01.24.12</a> </strong>).  The latest protocol for ACRIN 6684 had PET and MR imaging performed only at baseline, up to 2 weeks prior to standard treatment (chemo + radiation therapy).  Mid and post-therapy scans were eliminated from the protocol after Case 4, and only one patient had a retest FMISO scan. Of the 50 enrolled patients, 42 patients had evaluable imaging data for the primary aims of the study (see <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5065740/">Gerstner et al. 2016</a>).</p><p><u><strong>Note</strong><strong>:</strong></u> The MRI DWI/DTI series acquired through GE or Siemens scanners for 30 patients have been stripped of their b-values and diffusion gradient matrix DICOM header fields making them unable to be processed for ADC map production. The patients scanned with Philips MRI scanners are intact.</p>

ACRIN 6684多中心临床试验的宗旨在于探究基线状态下，^{18}F-FMISO正电子发射断层扫描(PET)摄取量（包括最大肿瘤与血液比值、缺氧体积）以及磁共振成像(MRI)参数（如T_{1}弛豫时间、血容量）与患者总体生存率、疾病进展时间以及6个月无进展生存期之间的关联性。此外，该试验还收集了标准脑癌数据，如卡诺夫斯基功能状态评分，以及包括MGMT状态、HIF1-α、GLUT1、CAIX、CD31和α-SMA表达检测在内的病理生物标志物。ACRIN 6684数据集包含两组感兴趣区域（VOI）的体积，包括增强脑肿瘤病变的描绘以及^{18}F-FMISO PET缺氧图谱。关于这些掩模的详细信息可在下方的详细描述标签中找到。更多关于试验的信息可在《研究方案》和《病例报告表》中查阅。在研究方案中，治疗开始后的2周内进行了MRI和PET的基线成像。^{18}F-FMISO已被证实有助于评估肿瘤的氧合状态，这可能影响其对放射治疗和化疗的反应。MRI扫描旨在测量与氧合状态相关的肿瘤特征，包括血流、血容量和血管大小的变化。原始方案中，基线成像后对^{18}F-FMISO PET仅进行了可选的测试-重测扫描。还包括化疗/放疗开始后的第3周和标准治疗结束后的第4周的PET和MRI扫描。在50名入组的患者中，只有一名患者进行了测试-重测^{18}F-FMISO扫描，并且在第4个病例后取消了治疗中及治疗后的扫描要求。当前的方案如图所示，可在网上找到（见《ACRIN 6684修订7，2012年1月24日》）。ACRIN 6684的最新方案仅在基线时进行PET和MRI成像，至标准治疗（化疗+放疗）前2周。在第4个病例后，取消了治疗中及治疗后的扫描，并且只有一名患者进行了重测^{18}F-FMISO扫描。在50名入组患者中，有42名患者的成像数据可用于研究的主要目标（参见Gerstner等人，2016年）。请注意：通过GE或Siemens扫描仪获得的30名患者的MRI DWI/DTI系列已被移除了其b值和扩散梯度矩阵DICOM头部字段，使其无法用于ADC图的生成。使用Philips MRI扫描仪的患者数据保持完整。