NCT00330109

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.

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
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 16, 2017

Status Verified

July 1, 2016

Enrollment Period

11.5 years

First QC Date

May 23, 2006

Last Update Submit

January 13, 2017

Conditions

Keywords

gliomamachine learningadvanced diagnostic imaging

Outcome Measures

Primary Outcomes (2)

  • 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.

    Pretreatment, 1 month post treatment and 7 months post treatment

  • 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.

    Pretreatment, 1 month post treatment and 7 months post treatment

Secondary Outcomes (1)

  • 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

    Pretreatment, 1 month post treatment and 7 months post treatment

Interventions

MRS ImagingPROCEDURE

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.

PET ScanningPROCEDURE

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must have histologically proven glioma
  • the patient or legally authorized representative must fully understand all elements of informed consent, and sign the consent form

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance SpectroscopyDiffusion Tensor Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, Neurological

Study Officials

  • Albert Murtha, MD, FRCPC

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 25, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 16, 2017

Record last verified: 2016-07

Locations