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Observational Connectomics in Adults Undergoing Resection of WHO II-IV Glioma

2026年11月3日 更新者：Northwell Health

A Prospective, Longitudinal, Multi-Institutional, Observational Study to Correlate Quantitative Changes of the Human Structural and Functional Connectome in Adults Undergoing Neurosurgical Resection of WHO II-IV Glioma

This observational study will create a large scale database (registry) of glioma patients' data across multiple participating institutions (hospitals) to study a range of clinical research questions.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The Glioma Connectome Project (GCP) is a study that seeks to use safe, powerful, non-invasive computing tools of machine learning and artificial intelligence, to take information from the functional MRI resting state (rs-fMRI) and the anatomic MRI using diffusion-weighted MRI to develop a comprehensive map of the brain. This "Virtual Brain" in the future may assist neurosurgeons in planning glioma surgery, understanding the cause of neurological deficits caused by the tumor, and a road map to help avert postoperative deficits, while also monitoring recovery of neurological function, as the brain "heals" or reorganizes itself through neuroplasticity.

The information from your MRI will be analyzed using algorithms to produce a map of the key tracts, functional hubs, and connections in the brain in terms of seven major networks: sensorimotor, visual, central executive (CEN), default mode (DMN), salience, dorsal attention (DAN) and limbic system. The completion of the project will advance diagnostics, brain imaging, brain tumor surgery, and provide the basis for new tools and drugs to treat brain injury and accelerate recovery of neurological function lost to the tumor, and treatments for the tumor, including surgery, radiation, chemotherapy.

The registry is being created to evaluate new computer-based technology that builds on ourknowledge of the human brain through the Glioma Connectome Project, which discovered that the brain could be divided into 180 areas per hemisphere or "parcellations", each with a function that is achieved by signaling other areas, forming broad networks, which influence brain function and brain health. Seven major networks are of great interest as they influence human neurological performance. These networks will be identified in the current study, throughout the course of the treatment for your glioma, by using the advanced neuroimaging which is standard of care at Lenox Hill Hospital.

研究类型

观察性的

注册 (估计的)

125

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • New York
      • New York、New York、美国、10075
        • 招聘中
        • Lenox Hill Brain Tumor Center
        • 副研究员：
          • David Langer, MD
        • 副研究员：
          • Tamika Wong, MPH
        • 首席研究员：
          • Randy D'Amico, MD
        • 副研究员：
          • John Boockvar, MD
        • 副研究员：
          • Olivia Albers, NP
        • 接触：
        • 接触：
        • 副研究员：
          • Netanel Ben-Shalom, MD, FNPS
        • 副研究员：
          • Taylor Winby, NP
        • 副研究员：
          • Elizabeth Lepski, NP

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Newly diagnosed and recurrent glioma (WHO grade II, III, IV) undergoing surgery

描述

Inclusion Criteria:

  1. Age > 18 years.
  2. Newly diagnosed patients (by MRI) suspected of having a brain tumor (WHO II,III, or IV) who will undergo surgery with histological confirmation or patients undergoing surgery for recurrent brain tumor (WHO grades II, III, IV) whose histology confirms glioma and/or treatment effect.
  3. Diffuse astrocytomas, multifocal gliomas, oligodendrogliomas, midline and brainstem gliomas are included.
  4. Previously treated (progressive, recurrent) gliomas are included. Thus, prior surgery, radiation therapy, anti-angiogenic therapy, electrical field therapy are not exclusions.
  5. Patient must be able to give informed consent. S/he must be able to read and understand English or there must be a qualified interpreter.
  6. Must be able to undergo sequential MRI in a facility that can perform 30-directional MRI for connectomic analyses.

Exclusion Criteria:

  1. Juvenile pilocytic glioma (WHO I)
  2. Histology that is non-glioma, e.g., brain metastases, craniopharyngioma, ependymoma, medulloblastoma, meningioma, lymphoma, tumefactive (demyelinative) plaque, abscess, germinoma, arachnoid cyst, epidermoid, PXA, DNET, ganglioglioma, central neurocytoma,
  3. Inability to give informed consent.
  4. Tissue samples obtained at surgery are insufficient/ or non-diagnostic for glioma
  5. Expected survival < 90 days due to primary disease or medical co-morbidities. (e.g. sepsis, pneumonia, organ failure)
  6. Inability to have a MRI due to cardiac pacemaker, implants, claustrophobia, allergy to gadolinium,
  7. Pregnancy. Because of potential risk of serial MRI to fetus, women of child-bearing age will need a pregnancy test and agree to contraceptive practices during the course of the study.
  8. Vulnerable population
  9. Medications. There are no restrictions on medications. Patients will receive best standard of care.
  10. Clinical Trials. Patients may also be enrolled in a clinical trial as a clinical trial is always recommended for patients with a glioma per NCCN guidelines.
  11. KPS < 40.
  12. Age < 17.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Newly diagnosed or recurrent glioma (WH) II, III, or IV)

Newly diagnosed patients (by MRI) suspected of having a glioma (WHO II,III, or IV) who will undergo surgery with histological confirmation or patients undergoing surgery for recurrent glioma (WHO grades II, III, IV) whose histology confirms glioma and/or treatment effect.
其他：Connectome MRI

Advanced MRI imaging done preoperatively, immediately following surgery, one month after surgery, and 3 months after surgery, then every 2 to 3 months for the duration of the study. These images are being done as standard of care and include functional MRI resting state (rs-fMRI) and the anatomic MRI using diffusion-weighted MRI to develop a comprehensive map of the brain.

其他名称：
  • 核磁共振
其他：Neuropsychological testing

Neuropsychological test that will be administered on an iPad, and should take no more than one hour to complete. Subjects will first complete a mini mental state exam to assess their mental status. This will only take 5-10 minutes to complete. Based on the results they may undergo all or some of the following neuropsychological tests which will be completed on an iPad:

  • Reaction Time
  • Rapid Visual Information Processing
  • Paired Associates Learning Delayed Matching to Sample
  • Verbal Recognition Memory
  • Multitasking Test
  • Spatial Working Memory
  • Emotion Recognition Task
其他名称：
  • Cambridge Cognition
  • Mini Mental State Exam

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Connectomic Metrics
大体时间：From enrollment up to 5 years.

FWHM (Full width-Half maximum)
From enrollment up to 5 years.
Connectomic Metrics
大体时间：From enrollment up to 5 years.

Network index
From enrollment up to 5 years.
Connectomic Metrics
大体时间：From enrollment up to 5 years.

Betweenness centrality (the value of each node to the whole network, defined by the fraction of the shortest paths passing through this node to all shortest paths that do not pass through it)
From enrollment up to 5 years.

次要结果测量

结果测量
措施说明
大体时间
KPS
大体时间：From enrollment up to 5 years.

The KPS describes a patient's functional status as a comprehensive 11-point scale correlating to percentage values ranging from 100% (no evidence of disease, no symptoms) to 0% (death). Each percentage reflects the patient's ability to perform daily activities and their level of independence or care needs. For instance, 100% indicates full independence, while 10% describes a moribund state with rapid disease progression.
From enrollment up to 5 years.
Progression-free survival
大体时间：From enrollment up to 5 years.

Progression-free survival (PFS) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease without it getting worse, growing, or spreading
From enrollment up to 5 years.
Overall survival (OS)
大体时间：From enrollment up to 5 years.

Overall survival (OS) is the length of time from either the date of diagnosis or the start of a treatment until death from any cause.
From enrollment up to 5 years.
Molecular markers and drivers of glioma growth
大体时间：From enrollment up to 5 years.

IDH mutational status, MGMT, ki-67, EGFR, p53, ATRX, TERT promoter, 1p19q chromosomal deletions, extent of resection, length of hospital stay
From enrollment up to 5 years.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Northwell Health

合作者

StacheStrong

调查人员

  • 首席研究员：Randy D'Amico, MD、Northwell Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月1日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2033年2月1日

研究注册日期

首次提交

2026年8月25日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 24-0143

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Clinical Data from the other study centers part of the Glioma Connectome Project (GCP) will be transferred pseudonymously.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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