跳至主要内容
临床试验/NCT02905643
NCT02905643终止不适用

The Use of Peak Height and Percentage Signal Recovery for Evaluation and Determination of Pseudoprogression in Glioblastoma Patients

Ascension Health0 个研究点目标入组 1 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
主要终点
Imaging parameter utility for pseudoprogression vs. true tumor growth

研究概览

简要总结

One-third of all primary brain tumors are astrocytomas, the most common type of glioma. Grade 4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of all gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates and median patient survival of just 12-15 months post-diagnosis. Treatment response is assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance images (MRI). However, radiation and chemotherapy cause inflammatory and necrotic changes which, like actual tumor progression itself, demonstrate contrast enhancement on the first post-treatment MRI scan. This enhancement eventually subsides (typically within 6 months of treatment) and is known as pseudoprogression (PsP). Currently, there is no gold standard noninvasive tool for distinguishing between pseudoprogression and progressive disease. Dynamic susceptibility-weighted contrast-enhanced perfusion MRI (DSC perfusion MRI) permits measurement of hemodynamic imaging variables. Previous literature reports attempted to use some or all of these metrics to assess their utility in distinguishing PsP from true cancer progression. These studies showed mixed results, likely due to a number of factors, including poor statistical power, poorly defined PsP, analysis of multiple cancer grades and types, and varied analysis methodologies. The investigators aim to address these issues in this study.

详细描述

See BRIEF SUMMARY section

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be 18 years of age or older.
  • Participants must be able to read and comprehend the English language.
  • In agreement with the care providing physician, participants must be willing to have surgery to remove possible brain tumor.
  • Participants must have a MRI scan within 24 hours after the tumor is removed (if a tumor is confirmed).
  • Participants must have the tumor analyzed by the laboratory and pathology departments and receive the diagnosis of glioblastoma.
  • Participants must be willing to follow the Stupp treatment protocol (this treatment plan and its' procedures are considered the standard for treating glioblastoma). (The Stupp protocol is the name of the radiation and chemotherapy plan that has been found to help in many cases of glioblastoma.)
  • Participants must be willing to follow any additional study procedures (including having all follow-up MRIs performed at St. Vincent 86th St).

排除标准

  • Participants are less than 18 years of age.
  • Participants have had surgery for your brain tumor and NOT received the diagnosis of glioblastoma
  • Participants and care providing physician have decided NOT to follow the Stupp protocol (treatment plan) for glioblastoma treatment. (Deviations or interruptions are allowed if clinically indicated)
  • Participants are not having a MRI scan within 24 hours after brain tumor surgery.
  • Participants are not willing to follow the study procedures.

结局指标

主要结局

Imaging parameter utility for pseudoprogression vs. true tumor growth

时间窗: Up to 24 months

The primary outcome of this study is to assess the utility of peak height, peak signal recovery, apparent diffusion coefficient, and cerebral blood volume (and their relative values) in determining, positive predictive values (PPV), negative predictive values (NPV), and likelihood ratios (LR) for identifying pseudo progression versus true tumor growth.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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