Multimodal Evaluation on Visual Pathway Predicts the Surgical Curative Effects in Sellar Area Tumors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change on functional connectivity of visual resting network
研究概览
简要总结
Sellar area tumors such as pituitary adenoma, craniopharyngioma and meningioma, etc, commonly lead to visual impairment symptoms. Patients suffer from a loss of visual acuity (VA) and visual field defects (VF) due to a local compression on the optic chiasma by the tumor. In the management of these patients, it is an important goal to evaluate their visual function throughout the treatment, so as to predict the outcome of the visual function .
Since the visual pathway contains a huge complex network of both structure and function, traditional simplex evaluation of VA and VF is obviously not enough. Former studies have revealed changes in the visual network and cortex structure in neurodegenerative diseases and optic neuritis, yet the functional and structural changes caused by local tumor compression and their relation to the visual cortex activity patterns needs further research.
The objective of this research is to asses the visual function in patients with sellar area tumor 1 week preoperatively (baseline),72 hours postoperatively(checking point 1) and at 3 months follow up(checkpoint 2). By using multimodal evaluation including visual resting and task state fMRI, diffusion tensor imaging (DTI), etc. The investigators aim to reveal the changes in functional connectivity (FC), amplitude of low frequency fluctuation (ALFF), regional homogeneity (REHO) ,visual cortex activity patterns and tract-based spatial statistics (TBSS).
详细描述
Detailed Description:
Study objective
Visual pathway contains both structural and functional network. When it is impacted by neurodegenerative diseases, neuritis or direct mechanical pressure, visual impairment occurs due to damage to the pathway. Former study on Parkinson's disease (Dagmar H. Heep et al, Radiology, 2017 ) found loss of functional connectivity in posterior and paracentral brain regions, while a study on optic neuritis (Yael Backner et al, JAMA Neurology,2018) showed an increase in functional connectivity and slightly loss in optic fiber integrity. Instead of simplex resting-state fMRI，the investigators of this study aim to assess:
- whether similar changes in functional networking occur when visual pathway is impacted by chiasma compression from tumors in sellar area (by resting-state fMRI).
- The correlation between local chiasma compression and visual cortex activation pattern ( by visual tasking-state fMRI).
- Changes and recovery of the white matter fiber structure in the visual pathway.
( by diffusion tensor imaging, DTI).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with sellar area tumors ( including pituitary adenoma,craniopharyngioma and meningioma) resulting a visual deficit (loss of visual acuity or visual field).
- •Male or female between 18y to 60y.
- •Patients treated with transsphenoidal surgery.
- •Patients agreeing to participate in the study and willing to sign an informed consent.
排除标准
- •tumor height ≥ 4cm.
- •Patients with recurrent tumors, previous craniotomy or gamma knife treatment
- •Visual impairment caused by other diseases.
- •Mental disorders, inability to cooperate with treatment and follow up visits.
- •Patients with other serious complications.
结局指标
主要结局
Change on functional connectivity of visual resting network
时间窗: Change from baseline (1 week preoperative) functional connectivity of visual resting network at 3 days postoperative and 3 moths postoperative.
Outcomes of visual resting state fMRI to assess the functional connectivity (FC) of visual resting network.
Change on signal strength of the visual cortex activation by visual tasking state fMRI (visual BOLD fMRI).
时间窗: Change from baseline (1 week preoperative) visual cortex activation signal strength at 3 days postoperative and 3 moths postoperative.
Outcomes of visual BOLD fMRI to assess the function of visual cortex by measuring the signal strength (T-test score) of the visual cortex activation.
Change on anatomical Connectivity of the posterior visual pathway
时间窗: Change from baseline (1 week preoperative) TBSS result at 3 days postoperative and 3 moths postoperative.
Outcomes of tract-based spatial statistics (TBSS) to assess the integrity of the white matter fibers in the posterior visual pathway.
次要结局
- Change on visual acuity(Change from baseline (1 week preoperative) visual acuity at 3 days postoperative and 3 moths postoperative.)
- Change on visual field.(Change from baseline (1 week preoperative) visual field at 3 days postoperative and 3 moths postoperative.)
- Change on amplitude of low frequency fluctuation (ALFF) of visual resting network(Change from baseline (1 week preoperative) ALFF of visual resting network at 3 days postoperative and 3 moths postoperative.)
- Change on regional homogeneity (REHO) of visual resting network(Change from baseline (1 week preoperative) REHO of visual resting network at 3 days postoperative and 3 moths postoperative.)
- Change on fractional atrophy (FA) value of the posterior visual pathway.(Change from baseline (1 week preoperative) FA of the posterior visual pathway at 3 days postoperative and 3 moths postoperative..)
- Change on axial diffusivity (AD) of the posterior visual pathway.(Change from baseline (1 week preoperative) AD value of the posterior visual pathway at 3 days postoperative and 3 moths postoperative..)
- Change on radial diffusivity (RD) of the posterior visual pathway.(Change from baseline (1 week preoperative) RD value of the posterior visual pathway at 3 days postoperative and 3 moths postoperative..)