NCT03091270

Brief Summary

This study was designed to collect a series of patients with gliomas which were involved in motor cortex to analyze difference accuracy of motor cortex localization between BOLD-fMRI and ZOOMit-fMRI.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

5.9 years

First QC Date

March 16, 2017

Last Update Submit

January 15, 2019

Conditions

Keywords

gliomasmotor functional cortexZOOMit-fMRIBOLD-fMRI

Outcome Measures

Primary Outcomes (1)

  • The accurate rate for hand motor cortex localization with BOLD-fMRI and ZOOMit-fMRI.

    To illustrate the accurate rate of hand motor cortex localization, the overlap indexes in BOLD-fMRI or ZOOMit-fMRI will be calculated. The results in BOLD-fMRI and ZOOMit-fMRI will be defined with 300 maximum value voxels via Statistical Parametric Mapping 8 (SPM8) software. According to the photographs and records of direct cortical stimulation (DCS) during awaken craniotomy, the DCS results will be confirmed as a global region with 5 mm diameter. Subsequently, we will overlap the BOLD-fMRI/ZOOMit-fMRI and DCS results then calculate the number of voxels overlapping. In this way, the overlap indexes can be calculated as a ratio between the number of voxels overlapping and the number of total voxels in BOLD-fMRI and ZOOMit-fMRI. We defined if the overlap index is larger than 0, the localization result is accurate. In contrast, if the overlap index is equal to zero, the localization result is inaccurate. Finally, the accurate rate of hand motor cortex localization can be calculated.

    From scanning with BOLD-fMRI and ZOOMit-fMRI to getting the overlap indexes,assessed up to 2 weeks in each patient.

Study Arms (2)

BOLD-fMRI

Identifying the motor functional cortex in glioma patients with BOLD-fMRI.

ZOOMit-fMRI

Identifying the motor functional cortex in glioma patients with ZOOMit-fMRI.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with gliomas which are closed to motor area (including primary motor area, premotor area and supplementary area), treated by awake craniotomy and intraoperative brain mapping

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Central Study Contacts

Tao Jiang, MD and PhD

CONTACT

Shengyu Fang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 27, 2017

Study Start

February 1, 2016

Primary Completion

January 1, 2022

Study Completion

January 1, 2025

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations