ClinicalTrials.gov
ClinicalTrials.gov Menu

Angiogenic Profile and Non-invasive Imaging May Predict Tumor Progression of High Risk Group Low Grade Glioma (LGG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00137488
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The low grade glioma (LGG) is a type of brain tumor which is generally more common in younger age group patients. Most patients with LGG undergo surgery which is mostly incomplete due to concern about loss of function. This is an incurable disease. More than half of these patients progress to a higher grade with a worse outcome within five years of their diagnosis and only one-third survive for up to ten years. Post-operative radiation treatment improves local control without survival advantage. Efforts are being made without great success to select the patients with a higher risk of progression based on physical characteristics and histological features.

Tumor vascularity is thought to be the key element in tumor progression. Tremendous progress has been made in functional imaging by using magnetic resonance imaging (MRI) 3-Tesla (3T) and in biotechnology which can be used to investigate angiogenic gene profiles in order to identify gene signature for these tumors. In this study the investigators are proposing that patients of LGG with a higher risk of tumor progression may be selected by functional imaging and angiogenic profiles. These higher risk patients may be candidates for post-operative radiation in the future with a potential survival benefit.


Condition or disease Intervention/treatment
Glioma Device: imaging and angiogenic profiles

Detailed Description:
Summary: Comprehensive analysis of the angiogenesis-related gene expression profiles and tumor perfusion of patients with LGG will provide a novel understanding of subgroup (low and high-risk) of LGG. Thus, this study will allow identifying clinically relevant factors predictive for tumor progression and to select patients in high-risk group for adjuvant radiation therapy.

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Angiogenic Profile and Non-invasive Imaging May Predict Tumor Progression of High Risk Group Low Grade Glioma (LGG)
Study Start Date : November 2005
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Device: imaging and angiogenic profiles
    Image tumor angiogenesis by DCE-MRI using 1.5- or 3-T MRI instruments (13,14,15) pre-and postoperatively (before biopsy or surgery).

Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients referred to Cross Cancer Institute between 2004 and 2005
Criteria

Inclusion Criteria:

  • Greater than 18 years of age
  • Brain tumor with no contrast enhancement on conventional MRI and confirmed histological of LGG
  • No adjustment treatment
  • Consent to participate in study
  • No contra-indication for dynamic contrast-enhanced (DCE)-MRI
Contacts and Locations
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137488


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Bassam Abdulkarim, MD AHS Cancer Control Alberta
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00137488     History of Changes
Other Study ID Numbers: CNS-09-0024/ethics 21656
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: April 2012

Keywords provided by AHS Cancer Control Alberta:
non-enhancing lesion
low grade glioma
high risk group selection

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue