Pituitary AdenomaNCT03591315
Clinical Study of Structural and Functional Evaluation of the Visual Pathway
An observational study of Pituitary Adenoma and Visual Impairment, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pituitary Adenoma, Visual Impairment, Sellar Tumor
- What is being tested?
- resting state fMRI, visual tasking state fMRI and diffusion tensor imaging
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2018to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Admitted sellar area tumor patients in the Neurosurgery Department at Xiangya Hospital of Central South University.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410001
Liu Z Xiong, MD/PhD, 13607318785, zhixiongliu@csu.edu.cn
About this study
Official title: Multimodal Evaluation on Visual Pathway Predicts the Surgical Curative Effects in Sellar Area Tumors
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).
Read the detailed description
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).
Method Participants: 60 adult participants (18-60 years old ) will be enrolled in the department of Neurosurgery at Xiangya Hospital of Central South University. The experimental arm will consist of 30 patients with visual impairment symptoms caused by chiasma compression by sellar area tumors (Tumor Group, TG). The control arm will consist of 30 healthy controls without any nervous system disease or visual impairment (Healthy Control Group, HC, control arm).
Study design: Transversal and Longitudinal, single center, comparative study is designed to evaluate functional and structural visual networking of sellar area tumor patients and healthy controls. The study involves assessment with resting-state fMRI, tasking-state fMRI and DTI. Patients of experimental arm will be evaluated by multimodal fMRI at 3 different checkpoints (baseline is 1 week preoperative ,checkpoint 1 is 72 hours postoperative ,checkpoint 2 is 3 months follow up ). Participants of control arm will be evaluated only once. Transversal comparison will be conducted between preoperative tumor patients and healthy controls, while longitudinal comparison will be within tumor group at baseline and two other different checkpoints.
MRI data acquisition and analysis strategy: In this study, the MRI data is acquired by Siemens 3.0T Prisma scanner, including sequences of mprage T1 , diffusion tensor imaging, resting-state fMRI and visual stimulation task fMRI. Resting-state fMRI longitudinal data analysis includes functional connectivity (FC), amplitude of low frequency fluctuation (ALFF) and regional homogeneity (REHO) to assess visual functional networking in both group. These Data wil be analysed using a multivariate approach and independent component analysis (ICA). Visual tasking fMRI will be conducted under classic black and white "chess board" simulation on each eye. For the evaluation of structural visual network, afferent visual pathway (optic tract and radiation ), fiber tracking as well as tract-based spatial statistics (TBSS) will be analyzed within both arms at baseline,checkpoint 1 and checkpoint 2 of the experimental arm will verify changing and recovering process of the visual pathway after chiasma decompression.
Primary outcomes
- The difference in visual pathway anatomy and functional network between preoperative sellar area tumor patients and healthy controls. Tumor patients will be evaluated clinically by visual acuity (VA), visual field (VF), tumor height and chiasma thickness.
- The verification of the correlation between patterns of chiasma compression and visual cortex activity. Revealing the difference of visual cortex activity patterns between both arms.
Secondary outcomes Throughout the 3 months follow up of the experimental arm patients, observe and verify the recovery process of both functional and structural visual network after chiasma decompression and evaluate its correlation with clinical visual function outcome.
Statistics
- An analysis of two sample T test between the two groups will be performed to assess the difference of FC,REHO,ALFF and visual cortex activity pattern between resting state data and data from the visual task of TG and HC.
- An analysis of variance (ANOVA) within TG group will be performed to assess the changes and recovery of FC, REHO, ALFF and visual cortex activity pattern via resting state data and data from the visual task's data.
Correlations will be explored between multimodal fMRI parameters (both functional and structural) and clinical criteria (e.g VA,VF, tumor size, visual outcome, etc).
- Conditions
- Pituitary Adenoma, Visual Impairment, Sellar Tumor, Neuroimaging
- Being tested
- resting state fMRI, visual tasking state fMRI, diffusion tensor imaging, automated visual field, visual acuity
- Keywords
- visual pathway, functional magnetic resonance imaging, pituitary adenoma
- Medical subject headings
- Pituitary Neoplasms, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resting state fMRIDiagnostic test
Also called V-RS
Define the visual resting state network.
visual tasking state fMRIDiagnostic test
Using visual task stimulation to identify the activation characteristic of primary visual cortex.
diffusion tensor imagingDiagnostic test
Also called DTI
Define the integrity of white matter fibers in the visual pathway.
automated visual fieldDiagnostic test
Also called VF
Identify the existence and type of visual field defect.
visual acuityDiagnostic test
Also called VA
Assess the visual acuity by using ETDRS scales.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on functional connectivity of visual resting network
Outcomes of visual resting state fMRI to assess the functional connectivity (FC) of visual resting network.
Measured: 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.
Measured: 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.
Measured: Change from baseline (1 week preoperative) TBSS result at 3 days postoperative and 3 moths postoperative.
Secondary outcomes (7)
Change on visual acuity
Outcomes of visual acuity test for evaluation of the visual function impairment and recovery.
Measured: Change from baseline (1 week preoperative) visual acuity at 3 days postoperative and 3 moths postoperative.
Change on visual field.
Visual Field Defects via Humphrey visual field chart, Mean Deviation and Standard Deviation in the patients' group at different checkpoints.
Measured: 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
Visual resting state fMRI data will be analysed to assess the ALFF data of visual resting network
Measured: 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
Outcomes of visual resting state fMRI to assess the regional homogeneity (REHO) of visual resting network.
Measured: 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.
Outcomes of fractional atrophy (FA) on the posterior visual pathway via diffusion tensor imaging (DTI) and fiber tractography.
Measured: 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.
Outcomes of axial diffusivity (AD) value on the posterior visual pathway via diffusion tensor imaging (DTI) and fiber tractography.
Measured: 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.
Outcomes of radial diffusivity (RD) value on the posterior visual pathway via diffusion tensor imaging (DTI) and fiber tractography.
Measured: Change from baseline (1 week preoperative) RD value of the posterior visual pathway at 3 days postoperative and 3 moths postoperative..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Z Xiong, MD/PhD, Study chair, Neurosurgery department, Xiangya Hospital of Central South University, Changsha, Hunan, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591315
- Sponsor's protocol ID
- 201611627
- Status last verified
- Jun 2018
- First submitted
- 21 Jun 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29297053Hepp 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.
PubMed 28952907
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Evaluation on Visual Pathway Predicts the Surgical Curative Effects in Sellar Area Tumors
- ClinicalTrials.gov ID
- NCT03591315
- Acronym / sponsor ID
- 201611627
- Conditions
- Pituitary Adenoma, Visual Impairment, Sellar Tumor, Neuroimaging
- Keywords
- visual pathway, functional magnetic resonance imaging, pituitary adenoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Method Participants: 60 adult participants (18-60 years old ) will be enrolled in the department of Neurosurgery at Xiangya Hospital of Central South University. The experimental arm will consist of 30 patients with visual impairment symptoms caused by chiasma compression by sellar area tumors (Tumor Group, TG). The control arm will consist of 30 healthy controls without any nervous system disease or visual impairment (Healthy Control Group, HC, control arm).
Study design: Transversal and Longitudinal, single center, comparative study is designed to evaluate functional and structural visual networking of sellar area tumor patients and healthy controls. The study involves assessment with resting-state fMRI, tasking-state fMRI and DTI. Patients of experimental arm will be evaluated by multimodal fMRI at 3 different checkpoints (baseline is 1 week preoperative ,checkpoint 1 is 72 hours postoperative ,checkpoint 2 is 3 months follow up ). Participants of control arm will be evaluated only once. Transversal comparison will be conducted between preoperative tumor patients and healthy controls, while longitudinal comparison will be within tumor group at baseline and two other different checkpoints.
MRI data acquisition and analysis strategy: In this study, the MRI data is acquired by Siemens 3.0T Prisma scanner, including sequences of mprage T1 , diffusion tensor imaging, resting-state fMRI and visual stimulation task fMRI. Resting-state fMRI longitudinal data analysis includes functional connectivity (FC), amplitude of low frequency fluctuation (ALFF) and regional homogeneity (REHO) to assess visual functional networking in both group. These Data wil be analysed using a multivariate approach and independent component analysis (ICA). Visual tasking fMRI will be conducted under classic black and white "chess board" simulation on each eye. For the evaluation of structural visual network, afferent visual pathway (optic tract and radiation ), fiber tracking as well as tract-based spatial statistics (TBSS) will be analyzed within both arms at baseline,checkpoint 1 and checkpoint 2 of the experimental arm will verify changing and recovering process of the visual pathway after chiasma decompression.
Primary outcomes
- The difference in visual pathway anatomy and functional network between preoperative sellar area tumor patients and healthy controls. Tumor patients will be evaluated clinically by visual acuity (VA), visual field (VF), tumor height and chiasma thickness.
- The verification of the correlation between patterns of chiasma compression and visual cortex activity. Revealing the difference of visual cortex activity patterns between both arms.
Secondary outcomes Throughout the 3 months follow up of the experimental arm patients, observe and verify the recovery process of both functional and structural visual network after chiasma decompression and evaluate its correlation with clinical visual function outcome.
Statistics
- An analysis of two sample T test between the two groups will be performed to assess the difference of FC,REHO,ALFF and visual cortex activity pattern between resting state data and data from the visual task of TG and HC.
- An analysis of variance (ANOVA) within TG group will be performed to assess the changes and recovery of FC, REHO, ALFF and visual cortex activity pattern via resting state data and data from the visual task's data.
Correlations will be explored between multimodal fMRI parameters (both functional and structural) and clinical criteria (e.g VA,VF, tumor size, visual outcome, etc).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TG group | – | Diagnostic Test: resting state fMRI, Diagnostic Test: visual tasking state fMRI, Diagnostic Test: diffusion tensor imaging, Diagnostic Test: automated visual field, Diagnostic Test: visual acuityPatients 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. |
| HC group | – | Diagnostic Test: resting state fMRI, Diagnostic Test: visual tasking state fMRI, Diagnostic Test: diffusion tensor imaging, Diagnostic Test: automated visual field, Diagnostic Test: visual acuityVolunteers 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Admitted sellar area tumor patients in the Neurosurgery Department at Xiangya Hospital of Central South University.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resting state fMRIAlso: V-RSDefine the visual resting state network. | Diagnostic test | HC group, TG group |
| visual tasking state fMRIUsing visual task stimulation to identify the activation characteristic of primary visual cortex. | Diagnostic test | HC group, TG group |
| diffusion tensor imagingAlso: DTIDefine the integrity of white matter fibers in the visual pathway. | Diagnostic test | HC group, TG group |
| automated visual fieldAlso: VFIdentify the existence and type of visual field defect. | Diagnostic test | HC group, TG group |
| visual acuityAlso: VAAssess the visual acuity by using ETDRS scales. | Diagnostic test | HC group, TG group |
Primary outcome
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.
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.
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.
7 secondary outcomes
Change on visual acuity
Time frame: Change from baseline (1 week preoperative) visual acuity at 3 days postoperative and 3 moths postoperative.
Change on visual field.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline (1 week preoperative) RD value of the posterior visual pathway at 3 days postoperative and 3 moths postoperative..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Results publication: PubMed 29297053Backner 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.
- Results publication: PubMed 28952907Hepp 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pituitary Adenoma
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingEarly Phase 1
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Cushing Disease, Pituitary Adenoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Z Xiong, MD/PhD study chair
Neurosurgery department, Xiangya Hospital of Central South University, Changsha, Hunan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Adenoma and Visual Impairment, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Z Xiong, MD/PhD (13607318785, zhixiongliu@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03591315, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.