Identification of Clinically Occult Glioma Cells and Characterization of Glioma Behavior Through Machine Learning Analysis of Advanced Imaging Technology
Primary Purpose
Glioma
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRS Imaging
PET Scanning
Diffusion Tensor Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Glioma focused on measuring glioma, machine learning, advanced diagnostic imaging
Eligibility Criteria
Inclusion Criteria: must have histologically proven glioma the patient or legally authorized representative must fully understand all elements of informed consent, and sign the consent form Exclusion Criteria: psychiatric conditions precluding informed consent medical or psychiatric condition precluding MRI or PET studies (e.g. pacemaker, aneurysm clips, neurostimulator, cochlear implant, severe claustrophobia/anxiety, pregnancy)
Sites / Locations
- Cross Cancer Institute
Outcomes
Primary Outcome Measures
image glioma patients with advanced imaging techniques to help us better characterize gliomas in the future
Eligible patients will be given the opportunity to undergo additional diagnostic imaging. These images will be anonymized and databased. the data will be analyzed using machine learning techniques.
create an image-based database to allow machine learning analysis of all the clinically available data
Eligible patients will be given the opportunity to undergo additional diagnostic imaging. These images will be anonymized and databased. the data will be analyzed using machine learning techniques.
Secondary Outcome Measures
through machine learning analysis, develop computer algorithms to allow us to automate tumour segmentation, predict tumour behaviour and predict location of clinically occult glioma cells
Eligible patients will be given the opportunity to undergo additional diagnostic imaging. These images will be anonymized and databased. the data will be analyzed using machine learning techniques.
Full Information
NCT ID
NCT00330109
First Posted
May 23, 2006
Last Updated
January 13, 2017
Sponsor
AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT00330109
Brief Title
Identification of Clinically Occult Glioma Cells and Characterization of Glioma Behavior Through Machine Learning Analysis of Advanced Imaging Technology
Official Title
Identification of Clinically Occult Glioma Cells and Characterization of Glioma Behavior Through Machine Learning Analysis of Advanced Imaging Technology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Gliomas are one of the most challenging tumors to treat, because areas of the apparently normal brain contain microscopic deposits of glioma cells; indeed, these occult cells are known to infiltrate several centimeters beyond the clinically apparent lesion visualized on standard computer tomography or magnetic resonance imaging (MR). Since it is not feasible to remove or radiate large volumes of the brain, it is important to target only the visible tumor and the infiltrated regions of the brain. However, due to the limited ability to detect occult glioma cells, clinicians currently add a uniform margin of 2 cm or more beyond the visible abnormality, and irradiate that volume. Evidence, however, suggests that glioma growth is not uniform - growth is favored in certain directions and impeded in others. This means it is important to determine, for each patient, which areas are at high risk of harboring occult cells. We propose to address this task by learning how gliomas grown, by applying Machine Learning algorithms to a database of images (obtained using various advanced imaging technologies: MRI, MRS, DTI, and MET-PET) from previous glioma patients. Advances will directly translate to improvements for patients.
Detailed Description
Gliomas are the most common primary brain tumors in adults; most are high-grade and have a high level of mortality. The standard treatment is to kill or remove the cancer cells. Of course, this can only work if the surgeon or radiologist can find these cells. Unfortunately, there are inevitably so-called "occult" cancer cells, which are not found even by today's sophisticated imaging techniques.
This proposal proposes a technology to predict the locations of these occult cells, by learning the growth patterns exhibited by gliomas in previous patients. We will also develop software tools that help both practitioners and researchers find gliomas similar to a current one, and that can autonomously find the tumor region within a brain image, which can save radiologists time, and perhaps help during surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
glioma, machine learning, advanced diagnostic imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
MRS Imaging
Intervention Description
Performed on a 3.0 Tesla Philips Intera MRI Unit (Best, Netherlands). Scout views and T2 transverse images are obtained to locate the tumor in conjunction with any previous diagnostic images.
Intervention Type
Procedure
Intervention Name(s)
PET Scanning
Intervention Description
Using an Allegro scanner, the patient will be scanned for approximately 20-30 minutes. All emission scan data is processed by a multi-step procedure.
Intervention Type
Procedure
Intervention Name(s)
Diffusion Tensor Imaging
Intervention Description
Subjects will be scanned with a 3T Philips Intera MRI scanner for approximately 26 minutes for anatomical and DTI imaging. Total DTI acquisition time will be 6:06 minutes with 40 contiguous axial slices for full brain coverage.
Primary Outcome Measure Information:
Title
image glioma patients with advanced imaging techniques to help us better characterize gliomas in the future
Description
Eligible patients will be given the opportunity to undergo additional diagnostic imaging. These images will be anonymized and databased. the data will be analyzed using machine learning techniques.
Time Frame
Pretreatment, 1 month post treatment and 7 months post treatment
Title
create an image-based database to allow machine learning analysis of all the clinically available data
Description
Eligible patients will be given the opportunity to undergo additional diagnostic imaging. These images will be anonymized and databased. the data will be analyzed using machine learning techniques.
Time Frame
Pretreatment, 1 month post treatment and 7 months post treatment
Secondary Outcome Measure Information:
Title
through machine learning analysis, develop computer algorithms to allow us to automate tumour segmentation, predict tumour behaviour and predict location of clinically occult glioma cells
Description
Eligible patients will be given the opportunity to undergo additional diagnostic imaging. These images will be anonymized and databased. the data will be analyzed using machine learning techniques.
Time Frame
Pretreatment, 1 month post treatment and 7 months post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must have histologically proven glioma
the patient or legally authorized representative must fully understand all elements of informed consent, and sign the consent form
Exclusion Criteria:
psychiatric conditions precluding informed consent
medical or psychiatric condition precluding MRI or PET studies (e.g. pacemaker, aneurysm clips, neurostimulator, cochlear implant, severe claustrophobia/anxiety, pregnancy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Murtha, MD, FRCPC
Organizational Affiliation
AHS Cancer Control Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Identification of Clinically Occult Glioma Cells and Characterization of Glioma Behavior Through Machine Learning Analysis of Advanced Imaging Technology
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