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临床试验/CTRI/2024/02/062536
CTRI/2024/02/062536尚未招募不适用

Voxelbox based structural and functional brain mapping in patients with space occupying lesions

BrainSightAI1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
This study will come to an end when at least 50 analyzable datasets are obtained for rs-fMRI and tb-fMRI (25 for language, 25 for motor).

研究概览

简要总结

The most commonly used imaging modalities in neuro-oncological surgery today are the structural magnetic resonance imaging and the task-based functional magnetic imaging, with the resting-state functional magnetic imaging being less commonly used. However, the latter is in many ways more efficient than the former.

We aim to utilize a resting-state connectomics approach augmented by machine learning, as mentioned below for space occupying lesions. This machine learning-augmented connectomics approach will minimize the risk of resecting functional networks during surgery and improve patient outcomes post-operation.

  1. To supplement the use of task-based functional magnetic resonance imaging by using resting-state fMRI which utilises  machine learning-generated brain masks.

Our machine learning has been trained, on 1200 datasets obtained from the Human Connectome Project, to not only build both task-positive and task-negative networks from preexisting HCP datasets, but also to use those datasets to derive these networks from the patients’ brains. These activations will be validated against those from a task-based functional magnetic imaging for language and motor networks.

  1. To quantify the extent of network and midline shift in the brain due to mass effect of space occupying lesion.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Brain SOLs
  • Eligible for surgical resection.

排除标准

  • Anyone < 18 and > 60 years of age
  • History of primary neurological disorders including seizure disorders/pre-existing disorders of development and degenerative disorders involving structural changes
  • Primary/pre-existing development and degenerative disorder involving structural changes
  • Primary/pre-existing Movement, Vision and speech disorders
  • Surgery in adjunct with cranial radiotherapy
  • Follow-up cases
  • Patients with contraindications to magnetic resonance imaging scanning
  • Pregnant women
  • Cases of meningioma
  • Non- compliance with fMRI protocol
  • Clinical symptoms not matching with SOL.

结局指标

主要结局

This study will come to an end when at least 50 analyzable datasets are obtained for rs-fMRI and tb-fMRI (25 for language, 25 for motor).

时间窗: The study is expected to take 12 months.

次要结局

  • There are no secondary outcomes.
  • There are no secondary outcomes.(N/A)

研究者

发起方
BrainSightAI
申办方类型
Other [For-profit company]
责任方
Principal Investigator
主要研究者

Ullas V Acharya

Manipal Hospital

研究点 (1)

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