Perioperative Evaluation of Cerebellar Tumors

• ClinicalTrials.gov Identifier: NCT04463979
• Recruitment Status: Recruiting
• First Posted: July 9, 2020
• Last Update Posted: December 5, 2022
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

This is a prospective, cohort study to evaluate the impact of cerebellar functional topography on perioperative outcomes related to cognition and motor ataxia in patients with cerebellar tumors.

Condition or disease	Intervention/treatment
Cerebellar Tumors; Brain Tumor	Other: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia

Detailed Description:

Purpose of the Study: This is a prospective, cohort study to evaluate the impact of cerebellar functional topography on perioperative outcomes related to cognition and motor ataxia in patients with cerebellar tumors.

Primary Aim: The primary aim of this study is to determine if patients with a cerebellar tumor are more likely to test positive for cerebellar cognitive affective syndrome than patients with non-cerebellar tumors. This information will be used to improve perioperative assessment in patients with tumors of the cerebellum.

Secondary Aim: To determine the impact of tumor location and cerebellar functional topography on perioperative outcomes (determined by standard of care neurological evaluation and brain images) in patients undergoing resection of cerebellar tumors. This information will be used to improve perioperative assessment in patients with tumors of the cerebellum.

Study Interventions: Thirty-three adult (≥18 years of age) patients with primary cerebellar brain tumors or metastatic brain tumors located in the cerebellum who will undergo surgery for tumor resection, and 33 adult patients with primary non-cerebellar brain tumors or metastatic tumors located in a non-cerebellar brain location who will also undergo surgery for tumor resection will be included in this study. The non-cerebellar brain tumor control group will be included for comparison. Participants in this study will undergo surgical resection of their cerebellar or brain tumor (as per standard of care), as well as clinical and radiographic assessment, including: neurological physical examination (including Karnofsky Performance Scale (KPS) if conducted per Standard of Care), and magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography, prior to, immediately after, at one-month, 6-month, and 1-year follow-up status post-surgical resection. These data will also be collected at 18-month (±60 days) and 24-month (±60 days) visits post-surgery, if regular office visits with the neurosurgeon are scheduled at these two time points. Only at baseline, the following will be conducted: Brief Ataxia Rating Scale (BARS) assessment score, Cerebellar Cognitive Affective Scale (CCAS/Schmahmann syndrome) scale score, Montreal Cognitive Assessment (MoCA) assessment, and a quality of life (QoL) assessment using the SF-36 questionnaire.

Data analysis: For each test item within the CCAS there is a threshold score allowing a pass/fail determination that differentiates CCAS-positive patients from CCAS-negative patients. The primary, study endpoint is the percentage of patients with a positive CCAS diagnosis prior to surgery. The investigators will evaluate whether CCAS is preferentially seen in association with any demographic or descriptive variables (particularly tumor location in the cerebellum) using chi-squared testing unless otherwise indicated. Demographic data including sex, age at time of brain tumor diagnosis and at surgery, education level completed, and dominant writing hand will be described. The distribution of each of the following preoperative variables will also be described: presenting symptom (cognitive, motor, or vestibular), brain lesion type (newly diagnosed vs recurrent), primary tumor site, primary tumor histology, presence or absence of a systemic burden of disease, presence of hydrocephalus or previous seizure in 30 days prior to surgery, prior surgery, prior whole brain radiation or stereotactic radiosurgery, initiation of antiepileptic or steroids prior to surgery, the indication for surgery. These data will be used to compare baseline characteristic of cerebellar tumor patients with non-cerebellar brain tumor patients. All statistical analysis will be performed by the investigators using Prism 4.0 (GraphPad Software, Inc.) and Stata v10 (StataCorp Lp). Significance will be assessed at alpha = 0.05.

Risks/Benefits: There will be physical or health-related risks to the surgical resection of the patients' cerebellar tumor according to the standard of care. Risk is also involved to the extent that privacy and confidentiality may be compromised. However, every reasonable effort will be made to limit breaches of privacy and confidentiality. Participants will not benefit directly from this study. However, the results of this work will help improve the perioperative assessment of patients with tumors of the cerebellum, which may improve rehabilitation efforts in this unique patient population.

Study Design

• Study Type: Observational
• Estimated Enrollment: 66 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Perioperative Evaluation of Cerebellar Tumors: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia
• Actual Study Start Date: February 28, 2021
• Estimated Primary Completion Date: April 1, 2024
• Estimated Study Completion Date: April 1, 2026

Groups and Cohorts

Group/Cohort	Intervention/treatment
Cerebellar Tumors; Thirty-three adult (≥18 years of age) patients with primary cerebellar tumors or metastatic tumors located in the cerebellum who will undergo surgery for tumor resection.	Other: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia; Participants in this study will undergo surgical resection of their cerebellar or brain tumor (as per standard of care), as well as clinical and radiographic assessment, including: neurological physical examination (including Karnofsky Performance Scale (KPS) if conducted per Standard of Care), and magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography, prior to, immediately after, at one-month, 6-month, and 1-year follow-up status post-surgical resection. These data will also be collected at 18-month (±60 days) and 24-month (±60 days) visits post-surgery, if regular office visits with the neurosurgeon are scheduled at these two time points. Only at baseline, the following will be conducted: Brief Ataxia Rating Scale (BARS) assessment score, Cerebellar Cognitive Affective Scale (CCAS/Schmahmann syndrome) scale score, Montreal Cognitive Assessment (MoCA) assessment, and a quality of life (QoL) assessment using the SF-36 questionnaire.
Brain Tumors; Thirty-three adult (≥18 years of age) patients with primary non-cerebellar brain tumors or metastatic tumors located in a non-cerebellar brain location who will also undergo surgery for tumor resection. This group will be included for comparison.	Other: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia; Participants in this study will undergo surgical resection of their cerebellar or brain tumor (as per standard of care), as well as clinical and radiographic assessment, including: neurological physical examination (including Karnofsky Performance Scale (KPS) if conducted per Standard of Care), and magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography, prior to, immediately after, at one-month, 6-month, and 1-year follow-up status post-surgical resection. These data will also be collected at 18-month (±60 days) and 24-month (±60 days) visits post-surgery, if regular office visits with the neurosurgeon are scheduled at these two time points. Only at baseline, the following will be conducted: Brief Ataxia Rating Scale (BARS) assessment score, Cerebellar Cognitive Affective Scale (CCAS/Schmahmann syndrome) scale score, Montreal Cognitive Assessment (MoCA) assessment, and a quality of life (QoL) assessment using the SF-36 questionnaire.

Outcome Measures

Primary Outcome Measures :

1. Percentage of cerebellar tumor patients with a positive cerebellar cognitive affective syndrome (CCAS) diagnosis prior to surgery [ Time Frame: Baseline ]
   CCAS/Schmahmann syndrome scale: 120 point scale (0=most severe cognitive impairment to 120=no cognitive impairment)
2. Percentage of brain non-cerebellar tumor patients with a positive cerebellar cognitive affective syndrome (CCAS) diagnosis prior to surgery [ Time Frame: Baseline ]
   CCAS/Schmahmann syndrome scale: 120 point scale (0=most severe cognitive impairment to 120=no cognitive impairment)

Secondary Outcome Measures :

1. Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors [ Time Frame: Discharge (1-2 days after surgery) ]
   "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
2. Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors [ Time Frame: 1 month after surgery ]
   "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
3. Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors [ Time Frame: 6 months after surgery ]
   "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
4. Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors [ Time Frame: 12 months after surgery ]
   "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
5. Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors [ Time Frame: 18 months after surgery ]
   "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
6. Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors [ Time Frame: 24 months after surgery ]
   "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
7. Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors [ Time Frame: Discharge (1-2 days after surgery) ]
   "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
8. Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors [ Time Frame: 1 month after surgery ]
   "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
9. Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors [ Time Frame: 6 months after surgery ]
   "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
10. Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors [ Time Frame: 12 months after surgery ]
    "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
11. Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors [ Time Frame: 18 months after surgery ]
    "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
12. Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors [ Time Frame: 24 months after surgery ]
    "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Thirty-three adult (≥18 years of age) patients with primary cerebellar brain tumors or metastatic brain tumors located in the cerebellum who will undergo surgery for tumor resection, and 33 adult patients with primary non-cerebellar brain tumors or metastatic tumors located in a non-cerebellar brain location who will also undergo surgery for tumor resection will be included in this study. The non-cerebellar brain tumor control group will be included for comparison.

Criteria

Inclusion Criteria:

• ≥18 years of age
• Patients with primary cerebellar brain tumors or metastatic brain tumors located in the cerebellum who will undergo surgery for tumor resection, OR with primary non-cerebellar brain tumors or metastatic tumors located in a non-cerebellar brain location who will undergo surgery for tumor resection

Exclusion Criteria:

• Patients under the age of 18
• Patients with intracranial pathologies (e.g. stroke, vasculitis, infection, developmental anomalies, etc.) outside of the cerebellum
• Non-oncologic cerebellar pathologies (e.g. stroke, vasculitis, infection, developmental anomalies, primary cerebellar ataxias, etc.)
• Patients who are illiterate, are blind, or do not read or understand English
• Patients with a Karnofsky Performance Status score of equal to less than 40

Contacts and Locations

Contacts

Contact: Eric W Sankey, M.D.; 919-970-9408; eric.sankey@duke.edu

Contact: Claudia E Pamanes, MPH; 919-668-0897; claudia.pamanes@duke.edu

Locations

United States, North Carolina

Duke University Medical Center; Recruiting

Durham, North Carolina, United States, 27710

Contact: Eric W Sankey, MD 919-970-9408 eric.sankey@duke.edu

Contact: Claudia E Pamanes, MPH 919-668-0897 claudia.pamanes@duke.edu

Principal Investigator: Allan H Friedman, MD

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Allan H Friedman, MD; Duke Health

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04463979
• Other Study ID Numbers: Pro00105872
• First Posted: July 9, 2020
• Last Update Posted: December 5, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms; Cerebellar Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infratentorial Neoplasms; Cerebellar Diseases