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

Cerebral Metastases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156585
• Other study ID #: 05-063
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: January 13, 2015
• Start date: August 2005
• Est. completion date: April 2008

Study information

• Verified date: January 2015
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Metastases

Locations

Country	Name	City	State
Canada	Faculté de médecine, Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Martin Lepage

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI parameters	Tumor volume, Ktrans, ve, time at maximum signal enhancement, maximum signal difference, ADC, basal T1 value	Before treatment with the Gamma Knife	No