NCT00156585

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

2.7 years

First QC Date

September 7, 2005

Last Update Submit

January 13, 2015

Conditions

Cerebral Metastases

Keywords

cerebral metastasesdynamic contrast enhanced magnetic resonance imagingDCE-MRIgamma knife

Outcome Measures

Primary Outcomes (1)

  • MRI parameters

    Tumor volume, Ktrans, ve, time at maximum signal enhancement, maximum signal difference, ADC, basal T1 value

    Before treatment with the Gamma Knife

Eligibility Criteria

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

oncology clinic

You may not qualify if:

  • Pancranial radiotherapy
  • Residual postop lesion
  • Gliomas
  • Patients \< 18 years old
  • Anterior allergic reaction to gadolinium
  • Claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculté de médecine, Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Study Officials

  • Jean Chenard, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

August 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations

CA(1)