Cerebral MetastasesNCT00156585
Predictive Value of Dynamic Contrast Enhancement MRI on a Cerebral Tumor Response to Gamma Knife Treatment
An observational study of Cerebral Metastases, run by Martin Lepage at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Metastases
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: oncology clinic
Who may be able to join
- Patient with intracerebral lesion benign or malignant wich are not concerned by the exclusion criteria
Who cannot join
- Pancranial radiotherapy
- Residual postop lesion
- Gliomas
- Patients < 18 years old
- Anterior allergic reaction to gadolinium
- Claustrophobia.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Faculté de médecine, Université de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
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
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.
- Conditions
- Cerebral Metastases
- Keywords
- cerebral metastases, dynamic contrast enhanced magnetic resonance imaging, DCE-MRI, gamma knife
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI parameters
Tumor volume, Ktrans, ve, time at maximum signal enhancement, maximum signal difference, ADC, basal T1 value
Measured: Before treatment with the Gamma Knife
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Lepage
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martin Lepage, Université de Sherbrooke
- Investigators
- Jean Chenard, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156585
- Sponsor's protocol ID
- 05-063
- Status last verified
- Jan 2015
- First submitted
- 7 Sep 2005
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00156585
- Acronym / sponsor ID
- 05-063
- Conditions
- Cerebral Metastases
- Keywords
- cerebral metastases, dynamic contrast enhanced magnetic resonance imaging, DCE-MRI, gamma knife
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Martin LepageUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- oncology clinic
Key inclusion criteria (1 listed)
- Patient with intracerebral lesion benign or malignant wich are not concerned by the exclusion criteria
Key exclusion criteria (6 listed)
- Pancranial radiotherapy
- Residual postop lesion
- Gliomas
- Patients < 18 years old
- Anterior allergic reaction to gadolinium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRI parameters
Time frame: Before treatment with the Gamma Knife
Tumor volume, Ktrans, ve, time at maximum signal enhancement, maximum signal difference, ADC, basal T1 value
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Chenard, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Metastases, run by Martin Lepage at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI parameters (time frame: Before treatment with the Gamma Knife). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2015.