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临床试验/NCT01880008
NCT01880008已完成不适用

An Exploratory Study of Quantitative [18F]FLT-PET and Advanced MRI as Early Indicators of Treatment Response and Molecular Markers for Cell Proliferation in Patients With Glioblastoma Following Subtotal Resection

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Change in FLT uptake, measured by SUV tumor/SUV normal contralateral white matter

研究概览

简要总结

Glioblastoma is the most common primary malignant neoplasm of the adult brain. Even after multimodal therapy, outcomes remain poor, with a median survival of one year. Although advanced imaging methods have been suggested as molecular markers of prognosis and therapeutic response, these methods have not been validated for clinical use. In this exploratory, imaging-based, trial, thirty patients with a pathological diagnosis of glioblastoma will be followed prospectively for two years. The study examines how PET and MR imaging signals change following administration of a standard radio-chemotherapy treatment regimen to determine whether these imaging modalities can provide early indicators of response to therapeutic intervention. The investigators hypothesize that decreases in uptake of an investigational 18F-FLT PET tracer following treatment with radiation and chemotherapy will be a reliable predictor of glioblastoma response. In a more exploratory fashion, the investigators also will identify changes in diffusion and hypoxia MR imaging that may also correlate well with treatment response.

详细描述

Patients with glioblastoma will be imaged with FLT PET/CT followed by MRI. The FLT uptake will be correlated with advanced MRI markers of tumor progression to determine the ability of using FLT PET and MRI for predicting response to treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (> 18 yo) with a pathological diagnosis of malignant glioma (WHO grades III and IV, including all histological subtypes)
  • Surgical intervention includes subtotal resection or biopsy with MRI evidence of residual disease after resection
  • Patients with plan to undergo standard chemotherapy and radiation protocols including a combination of fractionated radiation and temozolomide
  • Preoperative Karnofsky performance score (KPS) of > 60
  • Willingness of patient and his/her partner to use contraceptive measures for duration of trial that will include PET studies.

排除标准

  • Patient refuses adjunctive therapy
  • Pregnancy
  • Karnofsky scale < 60
  • Inability to undergo MR imaging studies
  • Estimated GFR ≤ 60 ml/min (using GFR = 0.85*[140 - age(y)]*[bodyweight(kg)]/[72*Cr(mg/dl)] for women and GFR = [140 - age(y)]*[bodyweight(kg)]/[72*Cr(mg/dl)] for men).
  • Inability or unwillingness to follow instructions for both PET and MR imaging sessions.

结局指标

主要结局

Change in FLT uptake, measured by SUV tumor/SUV normal contralateral white matter

时间窗: Before and after chemotherapy/radiation therapy

Determines the change in FLT uptake as a result of chemotherapy/radiation therapy

次要结局

  • Survival(2 years)
  • Ki-67(At diagnosis)
  • Radiographic progression defined by MacDonald criteria(2 years)
  • O(6)-methylguanine DNA-methyltransferase (MGMT) activity(prior to treatment)
  • Time to progression(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Delphine L. Chen, MD

Assistant Professor of Radiology

Washington University School of Medicine

研究点 (1)

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