Clinical Study of Structural and Functional Evaluation of the Visual Pathway

NCT03591315 | Unknown

• 1 other identifier: 201611627
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Pituitary Adenoma; Visual Impairment; Sellar Tumor; Neuroimaging

Keywords

visual pathway; functional magnetic resonance imaging; pituitary adenoma

Outcome Measures

Primary Outcomes (3)

• Change on functional connectivity of visual resting network

  Outcomes of visual resting state fMRI to assess the functional connectivity (FC) of visual resting network.

  Change from baseline (1 week preoperative) functional connectivity of visual resting network at 3 days postoperative and 3 moths postoperative.

• Change on signal strength of the visual cortex activation by visual tasking state fMRI (visual BOLD fMRI).

  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 from baseline (1 week preoperative) visual cortex activation signal strength at 3 days postoperative and 3 moths postoperative.

• Change on anatomical Connectivity of the posterior visual pathway

  Outcomes of tract-based spatial statistics (TBSS) to assess the integrity of the white matter fibers in the posterior visual pathway.

  Change from baseline (1 week preoperative) TBSS result at 3 days postoperative and 3 moths postoperative.

Secondary Outcomes (7)

• 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..

Study Arms (2)

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; Diagnostic Test: visual tasking state fMRI; Diagnostic Test: diffusion tensor imaging; Diagnostic Test: automated visual field; Diagnostic Test: visual acuity

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; Diagnostic Test: visual tasking state fMRI; Diagnostic Test: diffusion tensor imaging; Diagnostic Test: automated visual field; Diagnostic Test: visual acuity

Interventions

resting state fMRI DIAGNOSTIC_TEST

Define the visual resting state network.

Also known as: V-RS

HC group; TG group

visual tasking state fMRI DIAGNOSTIC_TEST

Using visual task stimulation to identify the activation characteristic of primary visual cortex.

HC group; TG group

diffusion tensor imaging DIAGNOSTIC_TEST

Define the integrity of white matter fibers in the visual pathway.

Also known as: DTI

HC group; TG group

automated visual field DIAGNOSTIC_TEST

Identify the existence and type of visual field defect.

Also known as: VF

HC group; TG group

visual acuity DIAGNOSTIC_TEST

Assess the visual acuity by using ETDRS scales.

Also known as: VA

HC group; TG group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Admitted sellar area tumor patients in the Neurosurgery Department at Xiangya Hospital of Central South University.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410001, China

Location

Related Publications (2)

• Backner Y, Kuchling J, Massarwa S, Oberwahrenbrock T, Finke C, Bellmann-Strobl J, Ruprecht K, Brandt AU, Zimmermann H, Raz N, Paul F, Levin N. Anatomical Wiring and Functional Networking Changes in the Visual System Following Optic Neuritis. JAMA Neurol. 2018 Mar 1;75(3):287-295. doi: 10.1001/jamaneurol.2017.3880.

  PMID: 29297053 RESULT

• Hepp DH, Foncke EMJ, Olde Dubbelink KTE, van de Berg WDJ, Berendse HW, Schoonheim MM. Loss of Functional Connectivity in Patients with Parkinson Disease and Visual Hallucinations. Radiology. 2017 Dec;285(3):896-903. doi: 10.1148/radiol.2017170438. Epub 2017 Sep 27.

  PMID: 28952907 RESULT

MeSH Terms

Conditions

Pituitary Neoplasms; Vision Disorders

Interventions

Diffusion Tensor Imaging; Visual Field Tests; Visual Acuity

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques; Vision Tests; Diagnostic Techniques, Ophthalmological; Ocular Physiological Phenomena

Study Officials

• Liu Z Xiong, MD/PhD

  Neurosurgery department, Xiangya Hospital of Central South University, Changsha, Hunan, China

  STUDY CHAIR

Central Study Contacts

Liu Z Xiong, MD/PhD

CONTACT

13607318785; zhixiongliu@csu.edu.cn

Zhong W Ming, MD

CONTACT

18874002961; sjwkkarl@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 19, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 23, 2018

Record last verified: 2018-06

Locations

CN (1)