Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Predictive Value of Dynamic Contrast Enhancement MRI on a Cerebral Tumor Response to Gamma Knife Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Lepage, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00156585
First received: September 7, 2005
Last updated: January 13, 2015
Last verified: January 2015
  Purpose

Hypothesis: the pattern of MRI contrast enhancement after gadolinium injection is different in tumors that respond well to gamma knife.

We are going to acquire sequential T1-weighted images of brain lesions before, during and after injection of Gd-DTPA. This will be repeated before and after a treatment with gamma knife. We will then analyse our results to see if there are common enhancement characteristics between lesions that will respond well to the radiosurgery treatment. Response will be clinically assessed by tumor volume as determined by MRI approximately 4 to 6 months after treatment.


Condition
Cerebral Metastases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study of Predictive Value of Dynamic Contrast Enhancement Magnetic Resonance Imaging With Gadolinium on the Response of a Cerebral Tumor to a Treatment With Gamma Knife

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • MRI parameters [ Time Frame: Before treatment with the Gamma Knife ] [ Designated as safety issue: No ]
    Tumor volume, Ktrans, ve, time at maximum signal enhancement, maximum signal difference, ADC, basal T1 value


Enrollment: 31
Study Start Date: August 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

oncology clinic

Criteria

Inclusion Criteria:

  • Patient with intracerebral lesion benign or malignant wich are not concerned by the exclusion criteria

Exclusion Criteria:

  • Pancranial radiotherapy
  • Residual postop lesion
  • Gliomas
  • Patients < 18 years old
  • Anterior allergic reaction to gadolinium
  • Claustrophobia.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156585

Locations
Canada, Quebec
Faculté de médecine, Université de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Martin Lepage
Investigators
Principal Investigator: Jean Chenard, MD University of Sherbrooke
  More Information

No publications provided

Responsible Party: Martin Lepage, MD, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00156585     History of Changes
Other Study ID Numbers: 05-063
Study First Received: September 7, 2005
Last Updated: January 13, 2015
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
cerebral metastases
dynamic contrast enhanced magnetic resonance imaging
DCE-MRI
gamma knife

ClinicalTrials.gov processed this record on March 03, 2015