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Clinical Study of Structural and Functional Evaluation of the Visual Pathway

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ClinicalTrials.gov Identifier: NCT03591315
Recruitment Status : Not yet recruiting
First Posted : July 19, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:

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).


Condition or disease Intervention/treatment
Pituitary Adenoma Visual Impairment Sellar Tumor Neuroimaging Diagnostic Test: resting state fMRI Diagnostic Test: visual tasking state fMRI Diagnostic Test: diffusion tensor imaging Diagnostic Test: automated visual field Diagnostic Test: visual acuity

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodal Evaluation on Visual Pathway Predicts the Surgical Curative Effects in Sellar Area Tumors
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Group/Cohort Intervention/treatment
TG group
Patients with visual impairment caused by chiasma compression from sellar area tumors will undergo the following examinations: resting state fMRI, visual tasking state fMRI, diffusion tensor imaging (DTI), visual acuity and automated visual field test.
Diagnostic Test: resting state fMRI
Define the visual resting state network.
Other Name: V-RS

Diagnostic Test: visual tasking state fMRI
Using visual task stimulation to identify the activation characteristic of primary visual cortex.

Diagnostic Test: diffusion tensor imaging
Define the integrity of white matter fibers in the visual pathway.
Other Name: DTI

Diagnostic Test: automated visual field
Identify the existence and type of visual field defect.
Other Name: VF

Diagnostic Test: visual acuity
Assess the visual acuity by using ETDRS scales.
Other Name: VA

HC group
Volunteers with no visual impairment(visual acuity of both eyes >1.0) or Nervous System disease will undergo the following examinations: resting state fMRI, visual tasking state fMRI, diffusion tensor imaging (DTI), visual acuity and automated visual field test.
Diagnostic Test: resting state fMRI
Define the visual resting state network.
Other Name: V-RS

Diagnostic Test: visual tasking state fMRI
Using visual task stimulation to identify the activation characteristic of primary visual cortex.

Diagnostic Test: diffusion tensor imaging
Define the integrity of white matter fibers in the visual pathway.
Other Name: DTI

Diagnostic Test: automated visual field
Identify the existence and type of visual field defect.
Other Name: VF

Diagnostic Test: visual acuity
Assess the visual acuity by using ETDRS scales.
Other Name: VA




Primary Outcome Measures :
  1. Change on functional connectivity of visual resting network [ Time Frame: 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.

  2. Change on signal strength of the visual cortex activation by visual tasking state fMRI (visual BOLD fMRI). [ Time Frame: 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.

  3. Change on anatomical Connectivity of the posterior visual pathway [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change on visual acuity [ Time Frame: Change from baseline (1 week preoperative) visual acuity at 3 days postoperative and 3 moths postoperative. ]
    Outcomes of visual acuity test for evaluation of the visual function impairment and recovery.

  2. Change on visual field. [ Time Frame: Change from baseline (1 week preoperative) visual field at 3 days postoperative and 3 moths postoperative. ]
    Visual Field Defects via Humphrey visual field chart, Mean Deviation and Standard Deviation in the patients' group at different checkpoints.

  3. Change on amplitude of low frequency fluctuation (ALFF) of visual resting network [ Time Frame: Change from baseline (1 week preoperative) ALFF of visual resting network at 3 days postoperative and 3 moths postoperative. ]
    Visual resting state fMRI data will be analysed to assess the ALFF data of visual resting network

  4. Change on regional homogeneity (REHO) of visual resting network [ Time Frame: Change from baseline (1 week preoperative) REHO of visual resting network at 3 days postoperative and 3 moths postoperative. ]
    Outcomes of visual resting state fMRI to assess the regional homogeneity (REHO) of visual resting network.

  5. Change on fractional atrophy (FA) value of the posterior visual pathway. [ Time Frame: Change from baseline (1 week preoperative) FA of the posterior visual pathway at 3 days postoperative and 3 moths postoperative.. ]
    Outcomes of fractional atrophy (FA) on the posterior visual pathway via diffusion tensor imaging (DTI) and fiber tractography.

  6. Change on axial diffusivity (AD) of the posterior visual pathway. [ Time Frame: Change from baseline (1 week preoperative) AD value of the posterior visual pathway at 3 days postoperative and 3 moths postoperative.. ]
    Outcomes of axial diffusivity (AD) value on the posterior visual pathway via diffusion tensor imaging (DTI) and fiber tractography.

  7. Change on radial diffusivity (RD) of the posterior visual pathway. [ Time Frame: Change from baseline (1 week preoperative) RD value of the posterior visual pathway at 3 days postoperative and 3 moths postoperative.. ]
    Outcomes of radial diffusivity (RD) value on the posterior visual pathway via diffusion tensor imaging (DTI) and fiber tractography.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Admitted sellar area tumor patients in the Neurosurgery Department at Xiangya Hospital of Central South University.
Criteria

Inclusion Criteria:

  1. patients with sellar area tumors ( including pituitary adenoma,craniopharyngioma and meningioma) resulting a visual deficit (loss of visual acuity or visual field).
  2. Male or female between 18y to 60y.
  3. Patients treated with transsphenoidal surgery.
  4. Patients agreeing to participate in the study and willing to sign an informed consent.

Exclusion Criteria:

  1. tumor height ≥ 4cm.
  2. Patients with recurrent tumors, previous craniotomy or gamma knife treatment
  3. Visual impairment caused by other diseases.
  4. Mental disorders, inability to cooperate with treatment and follow up visits.
  5. Patients with other serious complications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591315


Contacts
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Contact: Liu Z Xiong, MD/PhD 13607318785 zhixiongliu@csu.edu.cn
Contact: Zhong W Ming, MD 18874002961 sjwkkarl@163.com

Locations
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China, Hunan
Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410001
Contact: Liu Z Xiong, MD/PhD    13607318785    zhixiongliu@csu.edu.cn   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
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Study Chair: Liu Z Xiong, MD/PhD Neurosurgery department, Xiangya Hospital of Central South University, Changsha, Hunan, China

Publications of Results:
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03591315     History of Changes
Other Study ID Numbers: 201611627
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangya Hospital of Central South University:
visual pathway
functional magnetic resonance imaging
pituitary adenoma
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Adenoma
Vision Disorders
Vision, Low
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms